Assayer Job Description Sample
Senior/Lead Analytical Development Associate
- People:LIVING each day with passion for building up and building out our Synlogic team
- Platform: Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
- Products: Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
- Promise: Building our company to launch multiple novel LIVING medicines – mastering a new frontier in medicine
- Develop clinical phase biological potency assays and establish product specifications, with support from the group lead.
- Develop assays to assess structure-function relationships and analytical characterization of the Synthetic Biotics™ to define critical quality attributes of the drug substance and drug product, with support from the group lead.
- Support bioassays used inthe GMP manufacturing, with support from the group.
- Prepare technical reports for all development activities and author SOPs in support of assay development.
- Support preparation of regulatory submissions, participate in their review and approval, and contribute in the development of strategies to comply with US and international regulatory standards.
- Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example.
- BS (MS preferred) in microbiology, biochemistry or related discipline with at least 3 and ideally 5+ years of experience in bioassay development for clinical and/or commercial-stage biological products
- Experience with potency assays for biotherapeutic products or probiotics
- Experience developing quantitative assays for enzyme kinetics, such as metabolite consumption or conversion of these assay formats for use as potency assays
- Experience qualifying/validating assays per ICH Q2(R1)
- Excellent oral and writing skills
- Quantitative and qualitative qPCR/PCR techniques
- Cell counting for in vitro and cell-based assays including cellometer or flow cytometry
- Endotoxin assay development for product release and chracterizaion
We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results. Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.
Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting. Our compassion for each other creates a safe environment for continuous risk taking and personal development. We connect with our colleagues by having fun together. We take our work seriously and value integrity in producing the highest quality work. We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team. We encourage openness, direct feedback and transparency in decision-making to enable trust and maintain the nimbleness of the group.
Genomics Research Associate
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Clinical Genetics and Genomics team is seeking an innovative and highly motivated scientist to join our world-class team. The selected scientist will be responsible for genomics biomarker assay development, optimization, validation and execution of biomarker analysis for BMS translational research and clinical programs. The scientist must have a strong background in genomics as well as experience with and understanding of immunology or immunoscience related disciplines.
Assay design and development: Understand program biology requirements working with the biomarker and program leads and help develop the genomics biomarker strategy and execution plan working with the technology leads.
Design, develop, optimize genomics and genetics biomarker assays and develop and execute the validation of these assays for clinical trial assays.
Key assay profiles likely to include NGS or qPCR based gene expression systems, genotyping or variant analysis utilizing NGS or qPCR or other methodologies.
This is a lab based position with a significant opportunity to interface with program teams to understand program requirements and background, assay and analysis requirements, analysis timelines, analysis needs
A significant part of time will be spent assisting development and analysis of validation data. A strong understanding of assay validation and fit for purpose assay validation requirements will be essential.
In case of outsourced studies, the incumbent will provide oversight of assay development and execution of sample analysis at the vendor.
Help to draft experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs.
Actively participate in internal/external collaboration, portfolio management groups and clinical study and biomarker execution teams.
Providing subject matter expertise for clinical and program teams as required.
Accurate record keeping of experiments and procedures
Observe technology developments and innovate on new methodology per team requirements.
Work closely with data analysis teams as well as sample management and clinical operation teams on programs.
Experience in genomics based studies of immunooncology, oncology immunology or related fields.
Masters Degree with 5 yrs experience or Phd with 2 years experience with relevant work experience.
Experience in clinical assay development for gene expression profiling assets.
Understanding of fit for purpose genomics assay validation principles for clinical assays.
Experience with genomics (NGS, qPCR) assay development, validation, troubleshooting, and reviewing of run QC data.
In-depth knowledge of different genomics platforms and technologies (for the clinic).
Familiarity with NGS and qPCR data analysis and QC to develop a strong interaction with the data analysis team.
Technical expertise with molecular technologies, including but not limited to: NGs, single cell NGS, PCR, quantitative real-time PCR, digital PCR, NanoString,and other relevant methodologies.
Must have strong organizational and interpersonal skills with excellent leadership skills.
Must be self-motivated, with demonstrated ability to work independently and learn quickly.
Must be goal oriented and focused on completing work on time.
Thrive in a highly interactive, fast-paced and dynamic team environment.
Must be able to quickly adapt to changing priorities and work well in fast pace environment and under pressure.
Ability to mentor others on technical operating systems
Ability to independently review and understand project proposals/plans
Ability to work in a matrixed team in a high pressure environment.
Excellent communication skills with ability to serve as key contact for program teams.
Must have excellent organization and record keeping skills
Must be highly resourceful and work across matrix teams.
Previous industry experience is a plus
Previous experience in a clinical laboratory setting is a plus
Bioinformatics and data interpretation fluency and ability to engage with Bioinformatics team to appropriately QC and query datasets.
Understanding of design of experiments, randomization of samples for clinical analysis.
Scientist,Translational Bioassays Laboratory Head
The Preclinical Development group works with bluebird bio's discovery platforms and translational research teams to generate the hypotheses, mechanism-of-action, and efficacy data that fuel the bluebird pipeline. We also work with our clinical and regulatory teams to generate the toxicology and biodistribution data that is critical to translating each of bluebird's innovative therapies safely from research into patients. In doing so, we continuously strive towards our mission to be the biotech world's best preclinical development organization for immunotherapy and gene therapy. Our valued associates experience room to grow their careers, a supportive, flexible and collaborative work environment, and respect for a diversity of experiences and perspectives.
Do you have excellent attention to detail? Are you an ardent learner who is always looking to expand your knowledge? Are you self-motivated and have the right 'get-it-done' attitude? The Translational Bioassay Development group at bluebird bio is seeking a Laboratory Head with the ability to balance a variety of technical responsibilities and priorities according to bluebird bio's growing need for preclinical and exploratory clinical assay support across our portfolio of cell and gene therapies.
The primary function of this role will be to manage a laboratory conducting preclinical and exploratory clinical translational assays across all therapeutic programs at bluebird bio. The successful candidate will work with several groups to implement the most appropriate assays towards the success of existing and new gene therapy programs, to support IND enabling studies, and transfer assays supporting early phase clinical studies. The successful candidate will drive the design, development, execution and analysis of assays in early clinical studies, such as enzyme assays, CFC, anti-drug antibody assessments, PCR, flow cytometry, HPLC, cytokine/chemokine determinations, and other biomarkers of pharmacokinetic, pharmacodynamic and clinical responses.
The successful candidate will have the opportunity to become part of an innovative, collaborative and energetic team that will develop assay analysis and visualization tools applicable to all bluebird bio programs.
Manage the qualification/validation and implementation of key assays to support IND-enabling studies in support of preclinical development.
Manage the transfer, validation/qualification and implementation of exploratory assays to support early phase clinical studies.
Review and analyze assay data for assurance of assay quality and consistency.
Interface closely with other functions including Immunotherapy, Translational Oncology, and Preclinical Research.
Work with head of Translational Bioassays to prepare data presentations and relevant updates to cross-functional teams.
Possess excellent organizational skills, with the ability to multi-task in an extremely fast-paced environment.
Strong scientific background in a relevant field (Biology, Biochemistry, Immunology, other), PhD with 4+ years of relevant experience or MSc with 8+ years of relevant experience within the biopharmaceutical industry.
Strong experience with assay development, particularly experience in qualification and validation of bioassays, e.g. biomarkers, flow cytometry, cell-based methods, molecular methods, PD, PK, , ADA and laboratory developed tests (LDT).
Significant experience and working knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
Experience managing direct reports and outside vendors as well as the ability to work successfully in a team-oriented environment.
Senior/Scientist, Bioanalytical & Formulation Development
Rubius Therapeutics is a biopharmaceutical company pioneering a new era of cellular medicines. Our proprietary RED PLATFORM™ was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and ready to-use cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our initial focus is to advance RCT™ product candidates for the treatment of rare diseases, cancer and autoimmune diseases by leveraging three distinct therapeutic modalities — cellular shielding, potent cell-cell interaction and tolerance induction. We plan to file our first Investigational New Drug application (IND) for RTX-134 in phenylketonuria during the first quarter of 2019. We are planning to file additional INDs in rare diseases, cancer and autoimmune diseases in 2019, 2020 and beyond.
The company, a 2017 “Fierce 15” award winner, was founded in 2013, is based in Cambridge, MA and is currently expanding across the all functions within the organization. Having completed our an initial public offering (Nasdaq: RUBY), we are well capitalized to execute our vision and strategy. For more information, please visit us at www.rubiustx.comor follow us on Twitter.
We are looking for a Senior Scientist/Scientist in Bioanalytical & Formulation development to join the Bioprocessing team to help establish and develop the production process for our RCT™ platform. This position will focus on bioanalytical and formulation development including assay qualification, validation and assay transfer. S/he will be involved in experimental design, hands-on manipulation of ex vivo derived cells, and analysis of a variety of generated data sets. This is a great opportunity to be exposed to aspects of stem cell biology as well as process development in a translational context.
- Perform cell characterization and process analysis using flow cytometry, cell morphological analysis, and potency assays
- Design, develop, and execute cellular and biochemical assay for cell quality and stability assessment
- Develop and qualify new testing methods
- Perform visual inspections and release tests of final products
- Serve as a technical liaison between quality control and other departments, vendors or contractors
- Write technical reports or documentation to support IND submission
- Responsible for developing method robustness and consistency prior to Tech Transfer to CMO
- Document and communicate results in a timely manner
- Present and communicate study results at company meetings
- Ph.D., MS or equivalent in bioengineering, chemical engineering, biology, biochemistry or related field
- Strong experience in Bioanalytical development including cell-based assay and protein analysis, specifically with complex biologics
- At least 2 years industrial experience with assay development, assay qualification/validation, or final product formulation
- Experience with red blood cells is a plus
- Knowledge of hematopoietic stem cell and mammalian biology
- Motivated, curious, and comfortable working with highly technical projects and personnel
- Comfortable delivering against challenging commitments
- Confident, execution focused, team-oriented, with an ability to thrive in an entrepreneurial environment
Scientist/Senior Scientist, Mass Spectroscopy
The Scientist/Senior Scientist, Mass Spectrometry will develop, implement and manage assay development using Mass Spectrometry to detect, characterize and quantify drug substances and drug products and their product and process impurities. The scope of activities will encompass all programs and support clinical, R&D, cellular and gene therapy products, including Plant Biosciences. This person will work within the Analytics, Formulations framework team to ensure compliance with FDA, APHIS, EPA and other regulatory Analytical Assay development needs.
Job Requirements and Responsibilities
Develop, implement, and maintain phase-appropriate Mass Spectrometry based Assays with responsibility for analytical methods and standard operating procedures (SOPs).
Prior experience with mRNA capping assay is required.
Prior development work with quantitative methods for small molecule Mass Spectrometry methods (positive and negative ion) for the testing and release assays is required.
This may include extractable and leachable testing
Method development for measurement of small molecule metabolites from biological matrices is required.
Large proteins identity testing by tryptic digest and peptide mapping experience is required.
Nucleotide sequence confirmation (identity testing) of DNA or RNA experience is preferred.
Analytical method development using HPLC, UHPLC or UPLC via MALS, UV, FLR, CAD, ELSD detectors is desired.
Size exclusion LC separation experience is a plus.
HILIC development experience for adaptation of assays to LC/MS-MS is desired.
Experience with of development of hydrophobic small molecule assays with detection by CAD or ELSD is desired.
Experience with particle and biological molecule sizing technologies and assays is a significant plus, including DLS, Nanosight or AUC.
Experience with Circular Dichroism, Differential Scanning Calorimetry and participation in biophysical characterization programs is a plus.
Sample process development experience using Sepax-like, spin columns, affinity columns or other chromatography methods is desired, but not essential.
Prior experience in the pre-qualification of analytical assays for Technology Transfer purposes is required. This includes the preparation of analytical methods and standard operating procedures (SOPs), Pre-qualification Plans and protocols and working with CRO organizations for their execution as needed.
Experience with Analytical testing of drug product or drug substance material from Phase 3 or commercial products is required.
Instrumentation housekeeping and maintenance / metrology of analytical Mass Spectrometry instrumentation, interfacing with with vendor PM agreements is desired, including the collection of calibration data and GLP based instrumentation recording.
Analytical testing of other in-house developed assays, backing up other analytical testing responsibilities is expected.
Train new staff in analytical assays, procedures, test methods and applicable regulations is required.
Organize the development of analytical assay development needs using Mass Spectrometry or Biophysical based methods, by seeking out and maintaining matrix-relationships within the organization is required.
Review and oversee testing results from internal and external testing CRO or academic partners completed by Mass Spectrometry based methods.
Assist Quality Assurance, Analytical Development and Process Development with other projects and tasks, where applicable.
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- A cover letter detailing your experiences with the job requirements as listed here should be submitted with your application for full application consideration.
Doctor of Philosophy / Master of Science degree in Chemistry, Biochemistry, Physical Chemistry or related field, with 5+ years industry experience developing analytical testing for commercial or late stage clinical or commercial products is preferred
Experience with required analytical methods as described, including within academic and industry settings is expected.
Knowledge of FDA regulations and standards, especially those pertaining to the analytical assays for testing, including USP methods typically used for drug product and drug substance release assays.
Writing and Language Abilities
Excellent oral communication, from presentation in one-on-one to larger groups is expected.
Ability to read, analyze, and interpret common scientific, patent and technical journals, financial reports, and legal documents is needed.
Ability to respond quickly and interactively to inquiries or needs from all stake holders is a requirement.
Intimate knowledge of Mass Spectrometry data acquisition software and data processing including library searching softwares is a requirement.
Familiarity with HPLC systems for Mass Spec data acquisition is required. Further knowledge of these softwares for processing data from other detectors or pursuance of data integrity goals is a significant plus.
To perform this job successfully, an individual should have knowledge of Microsoft Office software suite including Power point, Word and Excel programs.
Familiarity with Statistical processing software is a plus
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Specific vision abilities required by this job include close vision, color vision, peripheral vision and ability to adjust focus.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel, and the ability to talk or hear.
The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
Ability to move containers of fluids less than 30 pounds is required.
Ability to wear Personal protective equipment including eyewear and gloves for extended periods of time is required.
- This position requires up to 20% travel.
Precision BioSciences, Inc. is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are achieving this with ARCUS, the first therapeutic-grade, naturally-derived genome editing system that uniquely combines the specificity and efficacy required to overcome lifes greatest genetic challenges. Learn more about the pioneers leading the next genetic revolution at:
Director/Sr. Director, Research Assays
Director/Sr. Director, Research Assays
CRISPR Therapeutics is currently seeking a senior leader of Research Assays for a newly-created role to assume immediate responsibility for the development of a portfolio of assays to support our research efforts. This leader will build and lead an assay team and will work collaboratively with other leaders in the research and translational development space to support CRISPR platform optimization and therapeutic area basic research in our rapidly growing organization.
Responsibilities include collaborating with CRISPR platform scientists, discovery/pre-clinical scientists, and translational scientists to accomplish the following
Create and manage a "Book of Business" of assays that will support research efforts across the company
Identify and develop assays in support of CRISPR platform optimization
Support assay development for therapeutic area basic research and pre-clinical sciences
Identify fit for purpose commercial assays (in lieu of development)
Identify and manage vendors to conduct fit for purpose assays
Deploy external assays through technology transfer and vendor management practices
Develop novel assays to support objectives in discovery research to non-GLP IND enabling studies. Examples of discovery research assays include, but are not limited to
biological readout of functional disruption of molecular CRISPR targets
cellular assays for activation of innate immune response
quantitation of cell-based and in vivo CRISPR therapies in blood and tissue
detection of biomarkers of target engagement and therapy disposition
Measurement of CRISPR-related biology such as DNA insertion/deletion, homologous recombination, etc
Ability to oversee assay development pertaining to a variety of methods including biochemical, ELISA, histologic, HPLC, nucleic acid, flow, etc.
Lead a group of assay development scientists at CRISPR Therapeutics to ensure that all novel assays are developed and transferred in a high quality and timely manner
Manage vendor relationships and trouble shoot where necessary
Manage communications and build collaborative relationships with key stakeholders within Research, Translational Development, and external collaborators/ vendors.
Develop assays and reagents to support translational development that are validation ready. In this capacity, the individual will be expected to work closely with the translational development team to deliver novel research assays with line of sight to support clinical endpoint and biomarker assessment of patient samples from ongoing clinical studies.
Analyze, interpret, and draw conclusions supported by data; communicate findings to research peers, senior management, as well as communicate effectively through written reports to wider audiences.
Hire and manage scientific staff as needed. Serve as a mentor to other members of the research staff and foster a culture of scientific excellence and cross-functional collaboration.
PhD degree in relevant discipline (Immunology, Molecular Biology or Biochemistry), strong knowledge of analytical methods, with a minimum of 8 years' experience with drug discovery and/or development in a biopharmaceutical industry laboratory
Demonstrated excellence in teamwork and effective collaboration; flexibility in project focus, outstanding oral and written communication skills, and contribute solutions to challenging research and translational development questions
The preferred candidate will possess requisite skills, first-hand experience, and deep understanding of methods covering a broad range of research techniques as detailed below:
Biochemistry: Protein purification, characterization, and quantification;
Molecular biology: RNA quantification, recombinant DNA methods (conventional, Gibson, etc.); protein production in stable and transient expression systems, NextGen sequence analysis;
Immunochemistry: antibody characterization (e.g. kinetic analysis, epitope mapping), immunoassays including ELISA & western;
Histology: Basic as well as immunohistochemical characterization of frozen and fixed tissue from in-vivo studies, light and confocal microscopy, and quantification of immunohistochemical results using digital image analysis;
Cell-based assays such as flow cytometry
Collaborative – Openness, One Team
Undaunted – Fearless, Can-do attitude
Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
Entrepreneurial Spirit – Proactive. Ownership mindset.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
Buyer I, Purchasing Specialist
RequirementsEXPERIENCE AND QUALIFICATIONS:* Bachelor's degree in Business, Supply Chain Management, Science, Engineering or a related field * Minimum 5 years experience as a buyer in a manufacturing environment o Minimum 2 years of experience may be substituted with a Bachelor's degree * Experience running ERP/MRP Systems o Preferably JD Edwards* APICS (American Production and Inventory Control Society) certification a plus* A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level considerationKNOWLEDGE, SKILLS AND ABILITIES:* Strong mathematical fundamentals and analytical background o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion * Demonstrate a strong understanding of manufacturing environment * Track record of successful vendor management o Demonstrate superior negotiation skills * Excellent oral, written communication and interpersonal skills o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of inventory data o Effectively communicate inventory level goals and objectives o Effectively communicate performance goals and expectations to vendors * Proficiency in MS Office Suite o Experience with standard data analysis tools and the quantitative background to advance this knowledge on the job is expected* A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding purchasing environment with changing prioritiesPHYSICAL DEMANDS:This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.WORK ENVIRONMENT:Traditional manufacturing office environment. * 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)Apply On-lineSend This Job to a FriendText goes hereCloseItem successfully added to cart!Catalog
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Principal Scientist, Cell-Based Assays, Cancer Vaccine & Immunotherapeutics
Pfizer's Cancer Vaccine & Immunotherapeutics (CVIT) group in La Jolla, CA is developing state-of-the-art cancer vaccine and oncolytic virus-based immunotherapy regimens that will benefit cancer patients.
We are seeking a Principal Scientist Cell-Based/Virology Assay Lead to join the Molecular & Cellular Biology team in CVIT. The successful applicant will use their extensive knowledge and hands on experience of cell biology, virology (BSL2/BSL2+ viruses), and associated cell-based assays to support cancer vaccine discovery and development projects. They will have a passion for research, a track record of success in this area, excellent communication skills and strong management experience. Previous industry experience with a solid foundation in vaccine or drug discovery would be an advantage.
This is a laboratory based role with supervisory responsibilities (for 2 or more scientists in the Cell Biology team). Areas of responsibility will include the co-ordination and execution of established cell-based virology assays, and the maintenance/ supply of multiple cell lines to end-users (96-well plate to Cell-factory scale). Additional scientific and technical/laboratory contributions to exploratory assays and novel assay development will also be expected. They will be able to independently and proactively apply their knowledge in the design, execution, analysis and interpretation of experimental work. They will also provide troubleshooting assistance and identify opportunities/ technologies for quality and efficiency improvements. Additionally, as a member of project teams, they will be accountable for the delivery and critical appraisal of their results (and those of others), presenting them for review at meetings and specific project milestones.
Significant knowledge and hands-on technical experience in two or more of the following areas is essential: culture of diverse mammalian cell lines, including normal cells and/or primary cell isolation and maintenance; generation and selection of clonal recombinant cell lines; cell-based assays for virus characterization (e.g. plaque, virus replication, virus neutralization, cell viability); use of reporter cell lines and/or viruses; development, characterization of robust cell-based assays relevant to virology, oncology or immunology; monitoring of assay performance; statistical analysis and graphical representation of complex data sets.
Direct supervisory experience of scientists working in the above area(s) is highly desirable.
Additional experience in one or more of the following areas is preferred: cell-based assay automation; quantitative protein expression analysis (e.g. Western Blot, ELISA); development and/or execution of molecular assays (e.g. qPCR/qRT-PCR).
Laboratory and related work (60-80% of time) under minimal supervision:
Experimental design, execution, analysis & critical interpretation of results
Will have and maintain technical skills and experience in virology and cell-based assays as well as ensuring they are fully conversant with the operation and validation of all items of equipment or IT needed for experimentation, data analysis, storage, and data entry.
Will directly supervise a team of scientists, with indirect/matrix supervision of additional scientists, directing daily research activities.
Will be responsible for practicing real time performance management, conducting annual performance appraisals, and developing robust career development plans for direct reports.
- Will comply with all EH&S regulations and safe laboratory practices and identify/ act to reduce hazards and risks in the laboratory.
- Ph.D in biological sciences, cell biology, or virology with 4+ years relevant laboratory experience, preferably in an industrial setting
- M.S. in biological sciences, cell biology, or virology with 9+ years relevant laboratory experience, preferably in an industrial setting.
Ability to read, understand, and perform work from written protocols, concentrating on tasks for prolonged periods of time
Ability to perform mathematical calculations and moderately complex data analyses using software packages
Ability to stand, sit, walk, bend, and lift various lightweight items in a laboratory setting.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Required to work safely with BSL2/2+ infectious viruses (e.g. Vaccinia, adenovirus) and must receive and maintain required vaccinations for this work or provide satisfactory proof of same.
May be required to work on occasional evenings and/or weekends when experiments and/or schedule require this.
Reporting: CSO of CVIT > Director of Molecular & Cellular Biology > Cell Biology Team Lead > Role
Interactions: Regular interactions and communication with scientists in other functional lines within CVIT and Vaccine Research & Development. Additional interactions with other groups in Pfizer, external collaborators and/or CROs.
EEO & Employment Eligibility
Pfizer 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. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Associate Director / Director, In Vitro Assay Scientific Leader
Vertex Pharmaceuticals is seeking an In Vitro Assay Scientific Leader (Associate Director / Director) to lead the MedChem assay profiling and screening group. The Vertex team plays a vital role in generating weekly medicinal chemistry and primary screening assays that support selection of leads and clinical candidates. The team is mostly responsible for biologically complex and challenging disease-relevant phenotypic and target-based assay platforms. These assays require merging strong scientific skills in human cell and target biology, a high level of attention to detail with traditional high throughput processes and both scientific and operational leadership. Efforts span execution of small molecule and non-small molecule drug discovery projects and you would be expected work cross functionally to apply creative solutions, adapt and conceive new technology platforms to assay design and drive implementation in support of Vertex's drug discovery efforts.
Support multiple lead optimization and early research projects in parallel by effectively executing both small molecule and non-small molecule assays. This includes conceiving, designing and implementing assays to support MedChem and/or primary screening assays and advancing key insights in assay or compound design that can impact project goals.
Drive the industrialization of complex assays from limited bench level applications to robust drug discovery formats.
Apply scientific leadership and strong troubleshooting skills that clearly identify key scientific questions that then form the basis for executable plans.
Manage an experienced and tenured research staff with all incumbent supervisory responsibilities, while inspiring scientific innovation to drive performance
Communicate company objectives to team and lead execution in a clear and efficient manner to meet timelines.
Derive widespread peer respect through scientific leadership and the display of high ethical standards
Doctorate of Science (Ph.D.) in Biology, or related discipline and 10+ years productive and relevant post-doctoral employment experience in a drug discovery environment or Master of Science (MS) in Biology, or related discipline, and 12+ years productive and meaningful experience in a drug discovery environment.
Strong in vitro assay expertise. This includes utilizing of automation, complex data sets and various assay detection methodologies.
Established expertise in cell biology methodologies using primary cells or stem cells
Successful track record leading a multi-disciplinary scientific team engaged in difficult projects and communicating and advancing pharmacological insights that impact the direction of pre-clinical drug discovery projects. This includes demonstrated ability to lead/ supervise and a passion to encourage scientific innovation to multi-disciplinary teams and individuals
Ability to navigate and be successful in a fast-paced, highly–matrixed and collaborative, cross functional work environment
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Bristol-Myers Squibb has consolidated process development organization comprising Process Development Analytics (PDA), Molecular Biology (MB), Cell Line Development, Upstream and Downstream development in a new building in Hopewell, New Jersey. BMS' Hopewell site is part of New Jersey's "Biopharmaceutical Life Sciences Cluster," a concentrated area of biotechnology, medical device, and pharmaceutical companies.
Responsibilities of PDA Group
Ensures high quality in process protein and molecular analytical information is available to New Jersey Biologics Process Development so timely decisions can be made.
Collaborate with Process Development, Analytical Development, and Research and Development to ensure transfer of methods and information occurs seamlessly to partners.
Maintain alignment with the Analytic network on platform methods.
This position will be responsible for supporting analytical activities within Biologics Process Development.
Support in-process analytical testing for monoclonal antibodies and fusion proteins, including HPLC/UPLC, capillary electrophoresis, ELISA, qPCR, etc.
Establish bioanalytical assays for non-platform biologics process development.
Develop high throughput and automated assays for increasing assay efficiency and reducing assay variation.
Evaluate new analytical technologies for improving analytical capability and assay performance.
Support assay harmonization activities within the network groups.
Set up and maintain collaborative interactions with Research and Development, Molecular Analytics, Process Development and where appropriate with manufacturing groups.
Maintain state of the art knowledge, present at meetings and publish their results and author technical documents.
Sustain a safe and high performance laboratory environment.
Organize internal and external events.
The successful candidate will have:
Ph.D. in Analytical Biochemistry, Analytical Chemistry, Biotechnology, or related fields. Alternatively, a Master's degree in Analytical Biochemistry, Analytical Chemistry, Biotechnology, or equivalent with a minimum of 4 years of industry and/or academic experience in relevant fields.
Proficient in a variety of bioanalytical techniques, including HPLC, UPLC, capillary electrophoresis, ELISA and qPCR assays.
Preferably have molecular biology experience.
A basic understanding of cell line, upstream and downstream process development.
Experience in high throughput and automated assay development is a plus.
Proficient in Use of EMPOWER, SYMYX DEVLIMS, SYMYX ELN, Microsoft office applications and data analysis.
Excellent communication and organizational skills.
Working knowledge of statistical experimental design and data analysis.
Ability to work collaboratively in a team environment.
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