Dry Cell Tester Job Description Sample
Postdoctoral Fellow – Cell Line Development/Nanoscale Cell Culture Analytics
Career CategoryPostdoctoralJob Description
The Amgen Postdoctoral Program is committed to providing future scientists with an enriched environment to inspire innovation that will contribute to the development of human therapeutics.
The Cell Line Development group is responsible for the generation of highly productive manufacturing cell lines for Amgen's rich and diverse large molecule pipeline.
We are currently employing next generation nanoscale fluidic devices to miniaturize Cell Line Development processes. This novel technology enables simultaneous isolation, culturing and analysis of thousands of clonal cells lines.
The Postdoctoral Fellow will utilize their biochemistry and immunoassay expertise and work cross functionally with groups across Amgen to develop new high throughput, nanoscale assays to enable characterization of thousands of production cells lines for cell culture performance, protein production and product quality attributes relevant to Amgen's large molecule pipeline.
The assignment length is expected to be 3 years long.
PhD at the time of appointment
PhD at the time of appointment in a life science or engineering discipline
The successful candidate is a highly motivated and self-driven expert in cell biology and biochemistry with a strong publication record
Direct experience developing assays to quantify and characterize proteins
Experience with cell culture, protein purification, cytometry, micro/nanofluidic technology and or other analytical methods
Experience with data analysis and modeling
Proven experience working efficiently in a cross functional, multidiscipline team structure, and ability to execute projects independently
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Sr Manufacturing Project Specialist - Cell Therapy
Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life.
Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization?
Job Description Summary Overview/Role Purpose: The Readiness and Improvements Project Specialist is responsible for the Manufacturing aspects of campaign readiness, as it pertains to all Production suites and support areas. This is full cycle responsibility for the planning, implementation and delivery of safe, compliant, error-free set-up of documents and operations, and cost effective processes and procedures in a timely manner.
The R&I project specialist supports manufacturing readiness for all modules within product management; working cross-functionally and in collaboration with internal support departments, customers and Mfg. suites to develop or update procedures or steps, identify and escalate risks, communicate changes and plan for execution. As a direct member of Internal and Joint Project teams, R&I project specialists are involved in key processing decisions on a frequent basis; an in-depth understanding of the Manufacturing suites and procedures are necessary to ensure decisions are made in the best interest of Manufacturing. R&I specialists are expected to set up Manufacturing for success; thus allowing Mfg. to focus on execution and delivery of product in a safe, compliant, efficient manner while meeting the demands of the site and customer.
Additionally, the R&I project specialist is responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time. Key Accountabilities and Duties: · Manufacturing reviewer and approver of documents required for the campaign, including SOP’s, batch records, validation protocols and change controls (temporary and permanent). · Proficient in document creation, revision and review; utilizes available tools to ensure accuracy, including activity analyses, dry runs, mock set-ups and flow path analyses. · Drive and own improvement projects that support KPI’s, with a focus on cost, innovation, on-time delivery and quality. Manage projects from concept to completion; create and manage project plan, work cross-functionally to ensure right first time and provide adequate training to impacted areas. · Manufacturing project team member during campaign readiness phase. · Responsible for proper issue identification and resolution, adherence to schedule, communication and/or escalation of risks and mitigation strategies, and on time delivery of documents and training to the floor. · Attend IPT/JPT’s, technical, customer, BOM and ad-hoc meetings as the Manufacturing representative. · Responsible for Mfg. process specific checklists and timely completion of associated tasks within. · Collaborate with Manufacturing management and subject matter experts (SME’s) to develop or update documents and procedures that are accurate and meets the needs on the floor.
Minimum Required Qualifications/
· AS/BS in Biotechnology, Biology, Chemistry, or equivalent o Preferred area of study: Science related discipline o High School Diploma or Equivalent may be considered with relevant experience · 5-7 years Biotechnology, preferably Upstream and Downstream, or similar Manufacturing industry. (10+ years’ experience without AS/BS) · Excellent written (especially technical writing) and verbal communication skills. · Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules. · Attention to detail and good investigation, problem solving and organizational skills. · Familiarity with SAP system an advantage · Ability to work in MS Word, Excel, PowerPoint Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.
Research Tech IV - Stem Cell
Req ID: 18261
Employment Status: AF - Active
A Research Tech IV position is available within the newly established Center for Spatial and Functional Genomics at The Children's Hospital of Philadelphia Research Institute, an interdisciplinary institution dedicated to conducting basic, clinical and translational research on conditions and diseases that affect children. Visit http://www.research.chop.edu for more information about The Children's Hospital of Philadelphia Research Institute and its related programs.
A research technician is needed to join a strong interdisciplinary team involved in spanning both dry and wet lab approaches in order to elucidate the genetic basis of complex traits. This will include the development of novel methods combining stem cell biology, genetic analysis and genome-editing technology development.
These studies will build on the already seminal work that has emerged from key studies conducted at CHOP. The successful candidate will possess excellent communication and organizational skills, including detailed recordkeeping, computer literacy, and the ability to contribute to method development and validation. After initial training, this individual is expected to perform protocols independently with minimal guidance, with accuracy, discretion and good judgment, and will assist the PIs (Drs.
Struan F.A. Grant, Ophir Shalem and Naiara Aquizu Lopez) with the collection and analysis of data by properly conducting specific experiments. General position requirements include IPS cell handling, performing CRISPR-related methods, assisting in maintaining equipment, managing hazardous chemicals, lab upkeep, and other general responsibilities in laboratory operation as assigned or directed, in order to meet the goals and objectives of the laboratory group.
Job Responsibilities (Continued)
JOB SPECIFIC RESPONSIBILITIES:
1.IPS and hES cell handling
2.Perform routine calculations and maintains appropriate log books and lab notebooks.
3.Performs and assists in the planning of procedures on experimental samples as directed.
4.Uses and maintains laboratory equipment.
Job Responsibilities (Continued)
Interested individuals should submit their resume to http://www.research.chop.edu, Struan Grant, Abramson Research Center, The Children's Hospital of Philadelphia, Room 1102D, 3615 Civic Center Blvd., Philadelphia, PA 19104, email@example.com or firstname.lastname@example.org or email@example.com.
Required Licenses, Certifications, Registrations
Required Education and Experience
Minimum 2 years relevant laboratory experience beyond classroom / internship(s) required.
12 – 24 months advanced laboratory experience
Preferred Education, Experience & Cert/Lic
Prior experience as a lead technician or supervisor preferred
Additional Technical Requirements
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).
Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.
VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.
CHOP Careers Contact
2716 South Street, 6th Floor
Philadelphia, PA 19146
Nearest Major Market: Philadelphia
Job Segment: Medical, Medical Research, Clinical Research, Patient Care, Healthcare, Research
*Metal Cell Level II
Job Description: JOB SUMMARYWork as a team member to take a rough casting and condition it to the specifications that meet the customer's requirements by performing metal cleaning, finishing, dimensional inspection and FPI inspection.
Must be able to read and interpret Product Criteria (PC) and Activity Instructions (AI).
Operate hand grinding tools (both belt and stone).
Operate metal cleaning equipment, water flow and sonic equipment.
Adjust parts by use of presses, heat or other dimensional tooling.
Operate hand sandblast and auto blast units.
Prolonged gripping standing or sitting and pushing, pulling and lifting.
Moderate length of concentration
Must be able to function as a member of a team and be able to work under general supervision.
Must be able to work and function in a fast-paced environment.
Basic knowledge of computers
Must be able to maintain expected quality levels.
Job responsibilities and duties may include, but are not limited to, the following:
To become cross trained in order to perform ALL or MOST OF the duties listed below, with a main concentration in FPI Certified Level II duties. When necessary, the individual may be required to move castings to designated areas or perform other work-related duties as assigned:
Sandblast part by the PC
Fill and clean the blasting unit
Perform hazeblast operation
Inspect castings for possible scrap
Maintain the correct pressure and speed of the blast cabinets by the AI's and PC's
Finish castings to PC using stones, burrs, belts, templates and gages
Sandblast to surface finish
Conduct visual operation and primary inspection of casting
Input data in computer for collection
Use boroscope for inspection and fiber light
Perform decap/deburr operation
Perform sonic operation
Map weld areas
Operate comco machine
Operate water flow
Operate gauging equipment. Use of calipers, micrometer, height gauges, shim stock, scissors, pin, go no/go, step gages, Arbor presses and sonic equipment.
Input data for record keeping
Adjusting castings for PC compliance
Working with engineering on deviant castings and reworking to engineers instructions
Operate glassbead/table clean unit
Datum "C" drilling-Stators Cell Only-(considered add-a-skill op.)
Reroute nonconforming castings
FPI-Certified Position-Consisting of Level I and Level II
Surface preparation-removing contaminants by degreasing or sand blasting.
Application of proper penetrate and removal of excess penetrate
Emulsifying for the specific amount of time
Removal of excess water and drying of casting
Application of developer
Monitor gages on equipment and run daily and monthly test to insure system is operating within customer specifications
Complete routing card
Reading FPI defects to insure customer regulations
Employees are expected to work overtime as needed.
Clean work areas and maintain a clean work environment; perform 5S cleaning activities as required
- Skills and Abilities:
Employee must be able to:
Read parts to the .0001
Understand gauging and templates
Have finishing skills, (stones, burrs, belts, etc.)
Work independent as well as with a team
Able to read and follow written and verbal instruction
No previous experience required.
- Physical Demands:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Employee is required to execute the following:
Occasional bending, reaching, pushing and pulling when retrieving and moving various items
Lifting approximately 30% of the time. Typically, assistance would be provided for weights exceeding 35 pounds.
Hand grinding tools
Metal cleaning equipment
Template Haze blast
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Duties are performed in a manufacturing setting where compliance with applicable safety rules is required.
While performing the duties of this job, the employee will be required to work near moving mechanical parts and exposed to fumes or airborne particles, rather confined space, and some degree of extreme heat during summer months. The noise level is moderate.
Expected to assist in the implementation of EHS Values and policy statements and accompanying principals.
Comply with all department, facility, corporate and regulatory EHS regulations.
Wear all required personal protective equipment (PPE).
Report all job related illness and injuries (Per Employee Handbook).
Report all safety, health and environmental concerns to your supervisor in a timely manner.
Attend all EHS training
The products we manufacture are used in important industries - transporting goods and people; the defense of our country; critical energy infrastructure for hospitals and public safety. Livelihoods and lives depend upon the products we manufacture. What we do as an organization
is important and the first, and best, "line of defense" against non-conforming products escaping to our customers is you. A simple message: don't take it, don't make it, and don't pass it.
A minimum of a High School diploma or GED equivalency is required
Work Keys testing is PREFERRED.
Employees must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.
This position is subject to the International Traffic in Arms Regulations (ITAR) which required a U.S. person status. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.
Research Associate/Sr. Research Associate, Molecular And Cell Biology
Research Associate/Sr. Research Associate, Molecular and Cell Biology
If interested and qualified, please include Requisition # 2018-327 in the subject line when emailing resume to: firstname.lastname@example.org.
For more information on CRISPR Therapeutics, please click here.
We are seeking a Research Associate/Senior Research Associate to join an exciting, fast growing, and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will be integral in discovering and developing the next generation of genetic therapies for a wide range of indications. The position requires enthusiasm, passion, attention to detail, and a desire to create new medicines for patients.
Perform research requiring molecular biology techniques including cloning, qPCR, RNA and DNA purification, NGS library prep, Illumina library QC, DNA sequencing, and plate-based assays
Develop and optimize NGS assays that characterize and measure gene editing outcomes
Gather and analyze experimental data under the direction of the research scientist or group leader, present to key stakeholders
Communicate and coordinate with therapeutic groups on projects/experiments
Maintain laboratory equipment and facilities
BS or MS in biology or related discipline and 4+ years of relevant research experience
Deep understanding of Illumina library prep protocols and extensive and diverse experiences in preparing Illumina libraries
Extensive experience operating instruments used in the genomics space, including those used for capillary electrophoresis, robotic liquid handling, and sequencing
Experience in working with wet and dry lab scientists and understanding large data sets
Excellent organizational skills and oral and written communication skills
Track record of challenging oneself to enhance scientific skills and knowledge
Ability to think strategically, manage time and workflow, and work independently as well as part of a results-oriented research team
2+ years of experience working in a NGS diagnostic laboratory and/or sequencing core lab
Prior research experience in biotech, particularly focusing on mammalian gene therapy or gene editing
Experience in developing off-the-shelf Illumina library preps protocols
Experience with Illumina Basespace and NGS analytical validation tools
Organization/Attention to Detail – Maintains highly organized focus on research work, demonstrates highly organized thinking and documentation, and complete follow through. Pursues all activities with diligence and completeness.
Communication and Teamwork – Effectively expresses ideas in written, visual, and oral context. The ability to work cooperatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
Passion – Creates an exciting environment where there is a true passion for the vision of CRISPR Therapeutics to bring novel medicines to patients suffering from serious diseases.
Results Orientation/Productive Work Habits – Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns / utilizes resources effectively and efficiently.
If interested and qualified, please include Requisition # 2018-327 in the subject line when emailing resume to: email@example.com.
For more information on CRISPR Therapeutics, please click here.
Lathe Cut Work Cell Operator
Founded in 1917, Parker Hannifin Corporation is a $12 billion, global company.
With annual sales of $12 billion in fiscal year 2017, Parker Hannifin is the world's leading diversified manufacturer of motion and control technologies and systems, providing precision-engineered solutions for a wide variety of mobile, industrial and aerospace markets. The company has operations in 50 countries around the world. Parker has increased its annual dividends paid to shareholders for 61 consecutive fiscal years, among the top five longest-running dividend-increase records in the S&P 500 index.
Parker's engineering expertise and broad range of core technologies uniquely positions the company to solve some of the world's greatest engineering challenges. By partnering with customers, Parker improves their productivity and profitability and seeks new ways to solve humanity's biggest challenges.
Conditions of Employment
Applicant must pass a drug screen and background check.
Applicant must have a high school diploma or equivalent.
Manufacturing experience is a plus.
JOB RESPONSIBILITIES (IN GENERAL, BUT NOT LIMITED TO)
Retrieve tubes to be processed from FIFO lanes
Transfer the extruded and cured dates to the production forms
Grind the tube to the correct OD size per spec sheet
Stripe the ground tube with the correct paint color and width
Mount and cut the striped tube. Cut the end pieces from the cut mandrel prior to placing the cut mandrel in the trough, cut in the opposite direction of good parts.
Check for Quality issues
Place a rod inside the cut gaskets and rake them to break apart
Place the rod in the duster and dust if specified or dry dust
Take the dusted rod out of the duster and check for quality issues (NCT)
Check the spec sheet for specific packaging requirements
Chart the grinder for centering twice per shift
Check the cutter for center twice per shift
Certify boxes according to procedure W10017
Move the finished pallet to the shipping stage area and repeat steps 1 through 13
Other duties, as assigned.
Knowledge of basic math functions (addition, subtraction, multiplication, and division)
Must be able to read, write, and comprehend English
Must be able to read simple blueprints
Knowledge and/or use of micrometers, calipers, and gages
Use tools (Allen wrenches, molds and tooling, open/box end wrenches, and screw drivers)
Keep accurate and legible records
Stand for extended periods of time
Handle 40 lbs. routinely
Work flexible hours, as needed
Pay, Benefits, Work Schedule
Parker offers a comprehensive benefits package which includes medical, dental, vision, short term disability, long term disability, and life insurance.
This position is for 3rd shift, which is 11:00 pm until 7:00 am with overtime.
Pay is competitive with local companies, and will be based on experience.
Equal Employment Opportunity
Parker is an Equal Opportunity and Affirmative Action Employer. Parker is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job related reasons regardless of race, ethnicity, color, religion, sex, sexual orientation, age, national origin, disability, gender identity, genetic information, veteran status, or any other status protected by law. U.S. Citizenship/Permanent Resident is required for most positions.
("Minority/Female/Disability/Veteran/VEVRAA Federal Contractor")
If you would like more information about Equal Employment Opportunity as an applicant under the law, please go to http://www.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
How To Apply
An applicant applies for a specific position on line @ Parker.com/careers.
The hiring process has a drug screening and background check and may include a series of interviews.
Scientist I Single Cell Transcriptomic Approaches To Cell Types In The Mouse Nervous System
The Allen Institute for Brain Science, located in Seattle, Washington, is committed to understanding how the brain works and helping to unlock the mysteries of neurological diseases and disorders affecting millions worldwide.
The Allen Institute is seeking an exceptional candidate who will be part of a Seattle-based multidisciplinary team within the Cell Types Program. The successful candidate will participate in high-throughput single cell transcriptome data generation and analysis to support the effort funded by the newly awarded BRAIN grant from the NIH, which aims to define all cell types in the adult mouse brain. The candidate will be a Ph.D. graduate in life sciences or computational biology and will possess strong experimental and computational skills. She/he will collaborate with several other departments on the identification and classification of cell types in the mouse nervous system.
Work within the Molecular Genetics team on experimental design, execution, and research associate training in order to generate large-scale single cell transcriptome datasets.
Work with Modeling, Analysis and Theory team to timely and iteratively analyze single cell data from the internal single cell transcriptomics pipeline and facilitate generation of cell type taxonomy.
Design and execute validation and follow-up experiments to place the transcriptomics results in the neurobiological context.
Write and publish manuscripts, grant progress reports and grant applications.
Present work internally and externally at conferences.
Evaluate new single cell RNA-seq platforms and techniques.
Work with Electrophysiology and Neuroanatomy teams to facilitate data organization and integration in an effort to create multimodal neuronal taxonomy.
Ph.D. in life sciences or computational biology (e.g., Neuroscience, Genomics, Genetics, or related field).
Knowledgeable in genomic data generation from primary tissues (rodent handling, dissection, single cell collection, molecular biology, and next generation sequencing).
Knowledgeable about developmental neurobiology and systems neurobiology
Knowledgeable about RNA-seq, ATAC-seq and/or ChIP-seq data
Proficiency in R and Linux shell scripting.
2+ years of experimental experience in genomic data generation from primary tissues (rodent handling, dissection, single cell collection, molecular biology, and next generation sequencing).
2+ years of experience working in a rodent model system studying a neurobiological problem in vivo (e.g., developmental neurobiology, systems neurobiology).
2+ years of computational experience working with RNA-seq, ATAC-seq and/or ChIP-seq data, preferably at the single cell level.
Ability to develop, test, implement, and share new experimental and computational tools quickly, in an iterative manner, after feedback from experimental, data production, and analysis teams.
Experience with additional programming languages (Perl, Python, Matlab) preferred.
Exceptional oral and written communication skills.
Ability to work independently as well as part of a team to meet aggressive timelines in a collaborative environment.
It is the policy of the Allen Institute to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the Allen Institute will provide reasonable accommodations for qualified individuals with disabilities.
Stem Cell Biologist/Senior Stem Cell Biologist
The Job Details are as follows:
The Organ Manufacturing Group seeks to expand its team with a Senior Stem Cell Biologist with the knowledge and capability to develop scalable methods to derive induced pluripotent stem cells (IPSCs) from primary cells and to differentiate IPSCs into airway epithelial, vascular endothelial, and mesenchymal progenitors.
This Senior Biologist will lead and grow a team of biologists and bioengineers to support our cutting edge 3-D bioprinting work by developing differentiation protocols and scalable production methods to supply cells for cellularization of 3D printed organ scaffolds. This position will also manage external development efforts at universities and partner companies, and contribute expertise to internal groups working the area of lung scaffold cellularization and cell-material interactions.
The ultimate goal of this work is the production of transplantable human organs.
Key Responsibilities & Accountabilities:
Leads IPSC-derived progenitor production development efforts internally and at partner sites
Oversees IPSC progenitor process development at partner sites
Establishes and maintains a deep understanding of current and emerging technology IPSC production and differentiation into airway epithelial, vascular endothelial, and mesenchymal lineages
Establishes and expands relationships with development partners
Provides hands-on reduction to practice for IPSC and IPSC derived progenitor derivation for the program, including the use of known methods as well as the discovery and development of novel method
Establishes validation standards for cell potency, genomic integrity, proliferation and viability
Oversees the selection and procurement of materials for IPSC and IPSC derived progenitor production
Provides expertise regarding IPSC and progenitor testing required for such cells to be used to cellularize 3D printed scaffolds
Devises test methods to evaluate performance and develop new testing standards
Provides expertise regarding cell expansion and validation of cell state
Follows existing test practices and develops additional experimental plans to achieve project milestones
Understands and adheres to program management critical path activities, and executes experimental plans cell production process development.
Maintains high level of communication with internal cross-functional R&D teams, as well as external vendors, and consultants
Conducts and supervises, when necessary, lab work and performance testing, and interprets data and results to provide guidance on design iterations
Makes recommendations and sets new directions for the project based on data, test results, and feedback from our partners
PhD degree in biology or biomedical engineering (or equivalent)
3-5 years of experience in an IPSC R&D environment, not inclusive of time in graduate school for Stem Cell Biologist; 5-10 years of experience in an IPSC R&D environment not inclusive of time in graduate school for Senior Stem Cell Biologist.
Experience in the derivation of IPSCs from primary cells
Experience in the derivation of airway epithelial OR vascular endothelial OR mesenchymal progenitors from IPSCs
Solid written and oral communication skills are necessary for this position
Other Knowledge, Skills & Abilities:
Experience leading teams and external collaborations is desirable
Experience in project management
Experience with scaling up cell production
Experience with quality validation of IPSCs and derivatives
Experience developing novel cell differentiation methods
Experience working under a quality system and medical product design preferred
Additional work showing versatility in other disciplines (chemical engineering, materials science or chemistry) is highly desired
Ability to utilize internal and external resources to resolve complex issues in creative, efficient, and effective ways
Must be comfortable working in a hands-on lab environment
Strong attention to detail
Familiar with good lab practices and patience
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
Director, Cell Line And Cell Culture Bioprocess Development
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com.
Reporting to the VP Manufacturing Sciences, this position will be responsible for providing strategic input relates to CMC decisions and will contribute significantly to the development and success of the Manufacturing Sciences team. Partner with other functional leaders from Analytical, Formulation, Supply Chain, CMO management and Quality in support of the project teams and of the organization.
This position will lead the Cell line and Cell Culture Bioprocess team for clinical and commercial manufacture of mAbs, fusion proteins and other novel biologics. The responsibilities include development of cell line and cell culture process, production of preclinical supplies at in-house bioprocess pilot plant, oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support of regulatory submissions. In addition, this individual will be accountable for overall management of the function such as resource planning, employee engagement and workflow enhancement.
Essential Functions and Duties
Key member of the Manufacturing Sciences leadership team to assess and support CMC strategy
Oversee cell line development for the selection of production cell line for master cell bank manufacturing.
Lead cell culture process development, optimization, characterization/validation, scale up and technology transfer to CMO's.
Manage process development experimental design, execution and writing process development plans/reports.
Introduce new technology to enhance workflow and capabilities.
Manage bioprocess suite, trouble-shooting of processes, instrumentation, and equipment to ensure timely in-house manufacturing to support preclinical animal studies.
Provide supervision for technology transfer and oversee CMO activities. Review, or approve batch records and SOPs; address production issues at CMO's in collaboration with quality and regulatory teams.
Acts as a mentor for the junior staff, provide coaching and emphasize best practices.
Partner with QA and Regulatory to support batch releases and regulatory submissions.
PhD in biochemistry, chemical/biochemical engineering or related disciplines
12+ years of in-depth technical experience in cell culture bioprocess development for protein drugs.
Solid knowledge and experiences in mammalian cell culture process engineering and process scale-up/scale-down design is essential.
Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
Strong business acumen and critical thinking
Proven experience in process characterization and validation.
Hands on experiences with technology transfer of manufacturing process.
Must be scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development.
Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.
Excellent interpersonal communication and presentation skills.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
All your information will be kept confidential according to EEO guidelines.
Cell Engineering Technician
2+ years' experience with air-sensitive material and hazardous chemicals
Above average manual dexterity and visual acuity are required in order to perform delicate assembly tasks.
Working knowledge of Windows and MS Office
Ability and passion to perform hands-on tasks
Good communication skills
High school diploma or equivalent. Engineering or chemistry related AS preferred.
60% of time hands-on tasks including cell dissection, delicate assembly of coin cells, and running tests on electronic equipment according to given instructions
Keep good record of the build information on Excel sheet
Work with air-sensitive materials using a glove box and/or in a dry room
Prepare chemical samples and run chemical analysis instruments such as GC-MS, SEM, ICP, and/or FTIR.
Support maintenance of the equipment including Arbin, Maccor, glove box, and temperature chamber
Report any issues related to the process and help find the solution
Desired skills (not required)
Hands-on lithium ion battery fabrication and testing
Familiar with chemical analysis such as GC-MS, SEM, ICP, and/or FTIR.
Experience with electronic/electrical equipment
Familiar with MATLAB, Python, and/or similar data analysis tool
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