Assayer Job Description Sample
Associate Chemist - Precious Metals Assay Lab
At BASF, we create chemistry through the power of connected minds. By balancing economic success with environmental protection and social responsibility, we are building a more sustainable future through chemistry. As the world’s leading chemical company, we help our customers in nearly every industry meet the current and future needs of society through science and innovation. We provide a challenging and rewarding work environment with a strong emphasis on process safety, as well as the safety of our employees and the communities we operate in, and are always working to form the best team—especially from within, through an emphasis on lifelong learning and development. And we are constantly striving to become an even better place to work. BASF has been recognized by Forbes Magazine as one of America’s Best Employers in 2016. Come join us on our journey to create solutions for a sustainable future! Where the Chemistry Happens… BASF’s Catalysts division is the world’s leading supplier of environmental and process catalysts. This position is an Associate Chemist in the Wet Chemistry Laboratory (Precious Metal Assay Services) in Union, NJ. The Precious Metals Assay Services Lab is the Corporate Center of Excellence for precious metals analysis at BASF; we are an analytical chemistry lab that specializes in high accuracy/precision analyses of precious metals, and precious metals containing materials, globally. Associate Chemist – Precious Metals Assay Lab (1704204) – Union, NJ Formula for Success: You Will…
Ensure on-time execution of analytical requests in the area of precious metals analysis, providing direct analytical support to BASF businesses.
Handle multiple tasks with a high degree of accuracy in a fast-paced analytical chemistry laboratory.
Must work well both independently and as a team member, assisting in other areas if necessary. Create Your Own Chemistry: What We Offer You… Adding value to our customers begins with adding value to you.
You@BASF is the suite of benefits, perks, programs and unique opportunities we offer to support you—the whole you—in all stages of your life and career. With you@BASF, you create your own chemistry. The total rewards that you receive as a BASF employee go way beyond a paycheck.
From competitive health and insurance plans, to robust retirement benefits that include company-matching contributions, to making sure you never stop learning, we believe investing in you is investing in our success. Working for a large, global organization, you’ll have a chance to grow professionally and personally, expand your network and build a rewarding and dynamic career. Ingredients for Success: What We Look for in You…
Bachelor's degree in Chemistry or a related discipline, combined with relevant work experience.
Excellent laboratory skills, including detailed recordkeeping, knowledge of safe handling of chemicals and equipment, academic knowledge and training in basic chemistry principles, procedures, and theories.
Prior background in wet chemistry (gravimetric assay, acid leaching, fire assay, elemental determination) is preferred.
Experience working in an ISO-compliant laboratory is a plus.
Job:REDE - Research & Development
Title:Associate Chemist - Precious Metals Assay Lab
Quality Assurance Specialist II - Assay Remediation
Plan, develop, lead and evaluate improvement and compliance projects relating to assay method remediation. Responsible for basic project management and documentation authoring (e.g. protocols, reports, regulatory submissions). Provide technical knowledge and/or support investigation teams in troubleshooting/problem solving activities as applicable. Provide recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works under only very general supervision to meet deadlines/goals.
Essential Duties and Responsibilities
Co-lead ongoing assay remediation daily department activities across all shifts for the Biochemistry Laboratory including supervision of assigned personnel when performing assays and when required assist other Quality areas in the successful performance of these activities.
Develop test procedures and generate protocols, reports and other documentation to support CTP revisions and validation
Assist in the development, establishment and monitoring of systems that focus on key indicators of laboratory control; including data mining.
Be directly involved in and lead multiple process/product improvement projects.These projects may be executed through CAPA, QWT, Kaizen, or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control.
Assist in laboratory audit ready status efforts in understanding FDA, Shire, and other regulatory and quality requirements.Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
Lead in the development of customer awareness and support activities for Biochemistry, and assist and drive such activities throughout the shifts.
Operational liaison with various customers including Manufacturing, Quality Assurance and Process Development and Technical Services.
Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback.Ensure employees have development plans.
Prepare, review and revise, as required, CTPs and SOPs.Write memos, reports, protocols, CPAs and other appropriate documentation as they pertain to Biochemistry operations and procedures.
Drive Lean principles such as 5S throughout daily work activities.
Demonstrated track record of managing multiple tasks and projects concurrently and driving projects to completion in a timely manner.
Strong organizational skills and ability to plan and suggest resolutions to technical problems.
Strong understanding of critical laboratory, manufacturing and facility processes
Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.
Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office).Capable of performing advanced data analysis through various applications software.
Strong interpersonal communication and influencing/negotiation skills.Must have strong verbal and written communication skills.
Represent the laboratory through technical presentations, material review board, management reviews, and other department presentations.
Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.
Must be able to understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
General knowledge of statistical techniques.Working knowledge of QSR, CFR, and USP.
Proficient with wide variety lab application software. Education and/or experience Bachelor's degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework with 3+ years of Quality experience -or- Master's Degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework with 2+ years of investigation experience.
Must be able to lift, push, pull and carry up to 25 lbs.
20/20 near vision required (corrected as acceptable).
Must be able to recognize and distinguish among the colors red, yellow, and blue.
In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning.Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.This may include additional hearing protection for loud areas.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment.
Must be able to work multiple shifts, including weekends.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
Will work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Must be able to work supplemental hours as necessary to complete work commitments.
Inside working conditions.
5% travel as applicable. Equal Employment Opportunity Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf Reasonable Accommodations Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information. Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Scientist II / Senior Scientist I, Assay Development
Description: Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at Stemcentrx, AbbVie's South San Francisco, CA location. POSITION DESCRIPTION: Scientist/Senior Scientist – Assay Development – Antibody Discovery As part of a talented and multi-disciplinary team advancing exciting new approaches to drug discovery and development, AbbVie Stemcentrx is looking for a highly motivated scientist with experience in assay development, specifically with a focus on antibody drug conjugates. This role is based at Stemcentrx and will contribute to a world-class team in identifying novel cancer stem cell targets and developing targeted antibody drug conjugate (ADC) therapies in oncology. The successful candidate will bring extensive knowledge of multiple assay platforms and strategies to an existing team of highly skilled and motivated scientists. Responsibilities
Support target discovery and validation efforts by independently developing and performing assays to evaluate biologic drug candidates, often using cell-based and ELISA assays
Support development efforts by designing and conducting IND enabling experiments, reagent antibody screening, potency, PK, and immunogenicity assay development
Design and implement In vitro assays to explore target biology and mechanisms of actions
Proactively seeks out and incorporates novel ideas in line with the group’s strategy to better characterize our antibody targets, toxins and ADCs
Draft IND and patent documents and occasionally present at scientific conferences andsymposiums
Qualifications: * BS or equivalent education with 7 years of experience or MS or equivalent education 5 of experience.
Highly motivated, goal oriented and independent scientist with proven technical expertise in development of novel assays
Demonstrated ability to independently design, execute and interpret critical assay development experiments to further ADC development
Strong expertise in antibody biology and characterization
Experience with cell imaging systems, flow cytometry, Luminex and MSD assay platforms.
Prior experience with ADCs; pharmacokinetic, immunogenicity and potency assays preferred
Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
Research & Development
Primary Location: USA-California-South San Francisco
Research & Development
Req ID: 1705092 Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Quality Analyst - Commercial Assay - Tucson, AZ
Freeport-McMoRan is a premier U.S.-based natural resources company with headquarters in Phoenix, Arizona. We operate large, long-lived, geographically diverse assets with significant proven and probable reserves of copper, gold and molybdenum. The company has a dynamic portfolio of operating, expansion and growth projects in the copper industry. Freeport-McMoRan is the world’s largest publicly traded copper producer, the world’s largest producer of molybdenum and a significant gold producer. We have a long and successful history of conducting our business in a safe, highly efficient and socially-responsible manner. We have the assets, the talent, the drive and the financial strength to provide attractive and rewarding careers for our employees. We encourage you to take some time to explore your career opportunities at Freeport-McMoRan. Provide technical support and expertise to assist in protecting FCX revenues in the important areas of product assay, weights, and quality control. Assist in evaluating and auditing all FCX assay settlement quality programs including customer and umpire to ensure FCX is paid for the actual metal contained in each shipment.
Perform statistical analysis on assays, weights, moisture determination and other commercial processes, present findings and recommendations, via technical reports, presentations, and/or verbal discussions
Work with Manager, Commercial Assay and Quality to prepare standards and specifications for processes, facilities, products, and tests in support of product quality assurance and improvements
Report status of quality control and analytical data quality and provide recommendations for corrective actions
Work with Manager, Commercial Assay and Quality to develop sampling criteria to assure proper assessment of shipment value; this includes determination of methodology and sampling parameters for minimum mass and sampling frequency and assurance preparation of proper sampling for assay an moisture determination
Monitor and provide guidance for weighing procedures at the loading and discharge ports; and assure compliance with relevant international standards and calibration procedures
Provide auditing and guidance for general QA/QC procedures at the material handling operations and analytical laboratories
Implement and monitor IMO and IMSBC procedures
Develop QA/QC procedures for logistics and international shipping
Assure that our port representatives are following correct IMO procedures, with proper certification and documentation for submission to authorities as required
Develop the relevant IMO test to assure compliance to regulations
Prepare a quarterly assay report to highlight any customer, umpire, or internal lab bias
Perform other duties as required
Minimum Qualifications* * Bachelor’s degree in Chemistry, Chemical Engineering or Material Engineeringandat least two (2) years of relevant work experience
Quality or Analytical Lab related work experience
Experience in statistical analysis
Knowledge of the principles and methods of chemical, laboratory and quality assurance analyses
Effective verbal and written communication
Ability to research and analyze information and draw valid conclusions
Efficient in computer applications, such as Microsoft, VBA and basic understanding of statistical data analysis software such as Minitab, SPSS and Design Expert
Ability to develop and maintain awareness of occupational hazards and safety precautions
Preferred* * Familiarity with Commercial Assay Exchange process
Knowledge of the principles and methods used in metallurgical and processing analyses
Knowledge and work experience in sampling methodologies and the relevant computational procedures
Experience with analytical chemistry instrumentation methods such as ICP OES, ICP MS, XRF, Titration, and Fire Assay
Certified Six Sigma Green or Black Belt
Ability to independently execute projects including new method development, analytical off-site support activities, and statistical analysis
Experience developing, organizing and maintaining laboratory quality records and supporting documentation for quality audits
Experience with ISO 9001 and ISO 17025 quality management systems
Strong background in laboratory quality control monitoring including statistical data analysis
Metallurgical or mineralogical experience
Skilled in computer programming
Criteria/Conditions* * Ability to understand and apply verbal and written work and safety-related instructions and procedures given in English
Ability to communicate in English with respect to job assignments, job procedures, and applicable safety standards
Work is performed in a mine or manufacturing plant setting, which may include exposure to extremes in temperature and humidity, moving mechanical parts, risk of electrical shock, toxic chemicals, explosives, fumes or airborne particles
While performing the duties of this job, the employee is required to stand, sit, demonstrate manual dexterity, climb stairs and ladders, and work on elevated platforms
Occasionally may be required to lift up to thirty (30) pounds during the course of the work day
Personal protective equipment is required when performing work in a mine, outdoor, manufacturing or plant environment, including hard hat, hearing protection, safety glasses, safety footwear, and as needed, respirator, rubber steel-toe boots, protective clothing, gloves and any other protective equipment as required
Freeport-McMoRan promotes a drug/alcohol free work environment through the use of mandatory pre-employment drug testing and on-going random drug testing as per applicable State Laws
International travel required 25% Freeport-McMoRan has reviewed the jobs at its various office and operating sites and determined that many of these jobs require employees to perform essential job functions that pose a direct threat to the safety or health of the employees performing these tasks or others. Accordingly, the Company has designated the following positions as safety-sensitive:
Site-based positions, or positions which require unescorted access to site-based operational areas, which are held by employees who are required to receive MSHA, OSHA, DOT, HAZWOPER and/or Hazard Recognition Training; or
Positions which are held by employees who operate equipment, machinery or motor vehicles in furtherance of performing the essential functions of their job duties, including operating motor vehicles while on Company business or travel (for this purpose “motor vehicles” includes Company owned or leased motor vehicles and personal motor vehicles used by employees in furtherance of Company business or while on Company travel); or
Positions which Freeport-McMoRan has designated as safety sensitive positions in the applicable job or position description and which upon further review continue to be designated as safety-sensitive based on an individualized assessment of the actual duties performed by a specifically identified employee. /Equal Opportunity Employer/Protected Veteran/Disability/
Title: *Quality Analyst
Research Associate II, Assay Services
Requisition Number 17-0094 Title Research Associate II, Assay Services City Gaithersburg State MD Description POSITION SUMMARY: A Research Associate II (RA II) is responsible for independently designing and executing experiments and analyzing the resulting data in support of reagent and assay development projects. This is a laboratory based position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day). The incumbent is expected to display a wide-degree of latitude, creativity and self-management. DUTIES AND RESPONSIBILITIES:
Execute on the design of experiments and implement plans with minimal guidance utilizing appropriate protocols
Establish schedules and scope of proposed experiments
Complete documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records
Analyze and prepare reagent and/or assay product documentation, organize and procure needed reagents, perform experiments, analyze data and document results
Exercise professional judgment to independently analyze experiment data
Employ self reliance in drawing experiment conclusions and interpreting results
Initiate the verification of accuracy and validity of data; correct any errors
Tender presentations for delivery to peer review groups using clear and concise methodologies
Provide descriptive statistical analysis via tables, graphs and other tools for summarizing research results
Propose viable options and educated recommendations for next steps
Lead general lab maintenance initiatives including maintaining laboratory supplies and equipment
Maintain and update electronic inventory list database (using Sharepoint), physical inventory and processing/aliquotting/vialing/labeling materials
Prepare, maintain and report reagent inventories for assigned methods
Utilize self-reliance in understanding and adhering to laboratory safety precautions and proper use of personal protective equipment
The incumbent is also expected to monitor the behaviors of others within the laboratory setting and provide guidance on best practices
Specific duties may vary depending upon departmental requirements Requirements EXPERIENCE AND QUALIFICATIONS:
Bachelor’s degree in life sciences, protein sciences, cellular/molecular biology, chemistry, biochemistry, biotechnology, or other related area is required
Master’s degree is preferred
Minimum 3 years of work experience (excluding academic internships) in reagent or assay development in an industrial setting is preferred; academic setting considered
Experience with running antibody-based assays, developing reagents and product development is desirable
Training in and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred
A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
Please view Equal Employment Opportunity Posters provided by OFCCP here.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Automation Engineer, Assay Application
Job Description This is an opportunity for a highly motivated automation engineer to work in a fast-paced and collaborative R&D environment developing simple, robust, and customer-focused solutions to facilitate genetic testing on the microarray platform.
Develops automated liquid handling solutions for preparing DNA samples to be used on Thermo Fisher’s microarray products.
This is a hands-on engineering position with a focus on development, validation and product commercialization.
Documentation under design control to ensure quality product development
Performs statistical analysis and conducts design of experiments.
Provides innovative ideas for new products and intellectual property.
Collaborates with molecular biologists, biochemists, bioinformatics, engineers, product managers, customer support, and other internal teams. Minimum Requirements/
Bachelor's degree + 5 years experience
or Masters + 3 years experience. Education in the following majors: Molecular Biology, Bioengineering, or related fields.
Multidisciplinary technical background is highly desirable.
Hands-on experience of operating and writing methods on automated liquid handling instruments (Beckman Coulter, Tecan, or Hamilton) is essential.
Understanding of assay development and validation is essential.
Can clearly document laboratory work and write SOPs.
Is a quick learner and can quickly deliver on goals.
Has a passion for problem solving and outside-the-box thinking.
Has good organizational skills.
Strong communication skills are essential.
Must be highly collaborative; must have the ability to work within a diverse team.
Self-motivated, independent, and a proactive driving force of execution.
Willingness to take on new challenges.
Able to adapt quickly to changing needs caused by time, budget, or other constraints.
Additional Favorable Experience:
Trained in ISO 13485, 21 CFR Part 820 Quality Systems Regulation, GLP/GMP.
Fluent in Microsoft Excel and Word
Working knowledge of JAVA scripting and/or Visual Basic
Statistical skills using current platforms e.g. JMP
Good mechanical aptitude
- IND-LSG Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Scientist II, Clinical Pharmacodynamic Assay Reagent Quality Control Manager (Nci)
Description:PROGRAM DESCRIPTION The Clinical Pharmacodynamic Program (CPP) is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute (NCI). The scope of work includes assay design, development, validation, fitness for purpose testing, transfer and support of assays to internal and external clinical laboratories, and clinical specimen analysis when required. The Internal Quality Control (IQC) laboratory within the CPP program is responsible for maintaining an inventory, quality control testing and distribution process for a large number of critical reagents to support the conduct of validated clinical pharmacodynamic assays across several technology platforms within network of internal and external laboratories. KEY ROLES/RESPONSIBILITIES The Scientist II, Clinical Pharmacodynamic Assay Reagent Quality Control Manager, will:
Manage a quality control laboratory responsible for performing incoming quality control testing on critical reagents for validated clinical pharmacodynamic assays across several technology platforms (i.e., multiplex immunofluorescence assays on slide based clinical biopsy analyses and circulating tumor cells; ELISA and Luminex assays on extracted clinical biopsies and cellular extracts, etc.
Oversee the procurement of bulk quantities of antibodies and other critical reagents and oversee their analytical and performance testing and subsequent release according to established reagent and clinical assay specifications
Oversee the production and release of custom assay control and proficiency specimens
Maintain a large inventory of assay critical reagents and associated electronic database
Oversee the distribution of assay critical reagents to external and internal laboratories
Supervise research associates in performing all laboratory operations, associated procurement and QC reporting activities
Qualifications:* BASIC QUALIFICATIONSTo be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: * Possession of a Doctoral degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research. (Additional qualifying experience may be substituted for the required education).
Foreign degrees must be evaluated for U.S. equivalency
In addition to educational requirements, at least two years of experience in assay reagent quality control and/or GMP manufacturing environment is required; post-doctoral training or experience is required for this position.
Demonstrated experience in antibody analytical and performance characterizations.
Must be able to obtain and maintain a security clearance
PREFERRED*QUALIFICATIONSCandidates with these desired skills will be given preferential consideration: * Experience with one or more of the following techniques: Sandwich ELISA, Luminex assays, slide based multiplex immunofluorescence assay staining and analysis methods, immunoassay development, antibody conjugation, protein purification, SDS-PAGE and Western blotting
Ability to independently develop and modify methods and techniques
Proficiency with Microsoft Office (Excel, Word, and PowerPoint) * Experience working in a GxP environment. Quantitative laboratory work in biochemistry, biology, chemistry, biotechnology
Experience in supervising laboratory staff from the entry technician level through associate scientist level bench scientists
Expected Competencies:* * Experience in the following areas: antibody and protein analytical and performance quality control evaluations
Experience in inventory of qualified assay reagents, including procurement, handling, testing and distribution
Ability to provide day to day supervision of a small group of research associates
Outstanding ability to collaborate with a diverse group of scientific staff responsible for initial development and validation of the clinical pharmacodynamic assays across several platforms and also core facilities providing testing support (histology, pathology, FFPE slide staining, whole slide image scanning, protein and antibody production, antibody conjugation, preclinical tissue generation, cell culture support, etc.).
Ability to communicate with program lead researchers in a demanding scientific environment through preparation of formal reports and presentations * A record of publication in refereed scientific literature
Ability to master novel technologies and instrumentation in response to changes in project priorities or breakthrough technological innovations; hands-on instrumentation work is required for this position
Ability to maintain precise records
* Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
Director / Associate Director, Assay Development, Translational Genomics
Job Summary : Directs a team of scientists that evaluates new methods, develops and validates genomic test procedures, and conducts custom projects in a dynamic, high-throughput molecular laboratory specializing in clinical trial testing. Responsible for developing budgets and tracking ongoing costs, establishing and adhering to timelines, maintaining regulatory compliance, and communicating genomic capabilities to internal and external stakeholders.
Duties and Responsibilities
Adhere to all Q Squared Solutions policies, procedures and employee handbook contents.
Directly lead the Assay Development Group, and contribute to the leadership and management of the Translational Genomics group, as directed.
Interface directly with external clients to determine requirements for special projects and develop experimental approaches to meet these requirements. Maintain an appropriate balance between existing capabilities and the development of new capabilities. Provide leadership to cross-functional teams to deliver special projects.
Develop and optimize molecular genomic test procedures through leadership of the Assay Development Group and close coordination with the Bioinformatics Group.
Directly, or through staff, determine an appropriate level of testing, verification and/or validation for new technology platforms and test procedures and develop corresponding plans and summary reports commensurate with Quality Systems requirements.
Responsible for projecting capacity, costs, personnel, equipment, reagents and time requirements for test procedures and/or technology platforms being developed or implemented, including ongoing calibration and maintenance where required.
Identify quality control metrics useful for the initial and ongoing evaluation of new test procedures and technology platforms, and provide a preliminary range of acceptability. Monitor and refine quality control metrics and provide feedback to Operations.
Transition newly developed test procedures to Laboratory Operations, coordinate with Operations to finalize training recommendations and requirements, and train personnel on new test procedures as needed.
Critically review new technology on an ongoing basis to understand suitability towards Q Squared Solutions business strategy.
Maintain a strong external scientific presence.
Function in a team environment, recognizing that priorities will shift according to business needs and maintain a flexible work schedule.
Other duties, as assigned.
Knowledge, Skills, and Abilities
Working knowledge of GLP, CLIA and HIPAA requirements.
Demonstrated expertise in contemporary molecular genomic technologies.
Excellent planning and organizational skills, and close attention to detail are essential.
Direct experience managing high-performing teams and developing team members.
Capable of managing multiple projects simultaneously.
Superior oral and written communications skills.
Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis.
Credentials and Experience
Master's degree or PhD in Molecular Genetics or related field, or equivalent combination of education and experience.
Minimum of 8 years molecular biology lab experience, with solid experience in a commercial setting and at least three years direct experience in a leadership role.
Experience in a clinical laboratory operating under GLP and/or CLIA guidelines and direct experience with clinical trials is preferred. EEO Minorities/Females/Protected Veterans/Disabled
Primary Location: USA-North Carolina-Durham
Manager, Car-T Assay Transfer
Other Locations: US- NJ- Warren
Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities will include, but are not limited to, the following: The Manager of Assay Transfer will be responsible for transferring qualified or validated analytical methods from the Analytical Research and Development group into QC Operations. This role will be responsible for collaborating on the validation efforts for all new analytical methods and primarily developing the analytical transfer plans into routine QC Operations. It is expected that the role will facilitate training for all QC operators. The successful candidate will demonstrate proficiency in technical writing, developing SOPs, training, and show high-level technical ability in flow cytometry, PCR, and ELISA. Critical to this role is an understanding and familiarity with principles of assay and equipment validation. This individual will work with minimal supervision to craft yearly performance objectives in-line with the goals of the functional area and drive the team to successful completion of all milestones.
Build systems and procedures for the transfer of analytical methods into QC including training plans, success metrics, and reporting policies.
Support the development, optimization and validation of analytical methods.
Qualify/transfer analytical methodology to/from quality control and contract laboratories.
Serve on and lead departmental and interdepartmental project teams.
Lead and/or participate in analytical investigations and engage subject matter experts as necessary.
Report and discuss analytical results and conclusions both orally and in writing.
Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
Review analytical data for completeness and correctness.
Adhere to all relevant compliance requirements. Skills/Knowledge required
Academic background in the Biological Sciences with demonstrated analytical capabilities.
Demonstrated technical ability in Flow Cytometry, ELISA, and PCR.
Experience managing teams and setting functional area objectives.
Experience supporting assay validation activities
Strong technical writing skills.
Strong problem-solving and troubleshooting skills.
Ability to work independently.
Strong verbal and written communication skills.
Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
Ability to provide scientific guidance, leadership and training to others within the department. Skills/Knowledge in the following areas are a plus
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances.
Familiarity with the USP and other compendia. #LI-POST Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Manager, CAR-T Assay Transfer
Warren, NJ, US
Job ID: 1700633
2018 MRL Assay Development Co-Op
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century.
Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal.
Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. The Bio-analytical LC-MS Lab within the PPDM organization at Merck Palo Alto is seeking an exceptional Co-op student to contribute to the understanding of the PK properties of novel therapeutic drug candidates across modalities This co-op position will consist in learning the basic principles and methodology of Liquid Chromatography- Mass Spectrometry (LC-MS) technology as applied towards biologics characterization and quantitation. This will involve working on absolute quantitation of protein drug therapeutics from bio-matrices as well as relative quantitation of protein post-translational modifications using mass-spectrometry.
Understanding of the fundamentals of quantitation using mass spectrometry will be preferred. This position will also focus on application of automation in the routine protein sample preparation for mass-spectrometry. This will involve establishing and optimizing workflows using the Agilent Bravo Assay Map robotic platform. Interest in learning and applying automation will be preferred.
Required: Candidates must be currently pursuing a BS/BA or MS/MA in: Biology, Biochemistry, Chemistry or relevant discipline
Candidates must have completed at least two full years of an undergraduate degree prior to the start of this co-op position
- Candidates must beavailable to work full-time for at least six (6) months beginning in Spring 2018
Superior communicationand interpersonal skills
Comfortable as a teamplayer with the ability to work independently Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.
All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf EEOC GINA Supplement at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf FTP2018 Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
JobBiology-Discovery Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Title:2018 MRL Assay Development Co-Op
Primary Location: NA-US-CA-Palo Alto
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