Qc/Ad Scientist Iii, Ngs

When you are part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With annual revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make meaningful contributions to the world.

Location/Division Specific Information
Work Location: Carlsbad, CA

At Microbial Manufacturing Services (MMS) a division of Thermo Fisher Scientific PSG Corporation (Patheon) we deliver, from process development through commercial supply, the expertise, and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

As part of the Quality Control (QC) Analytical Development (AD) team, you will be responsible for performing a variety of duties to support QC lab. The individual will evaluate, develop, and optimize analytical methods for complex testing of raw materials, plasmid drug substance and drug product, release, and stability samples. This individual will also participate in the validation of analytical methods, in support of dispositioning product and/or raw materials, while ensuring compliance with PSG directives and procedures, customer requirements and regulatory standards.

What will you do?

• Design and conduct experiments for the development or optimization of analytical methods, applying proven understanding in process analytics with knowledge of DoE and statistics.
• Prepare status updates, protocols, development/qualification reports. Participate in weekly project team meetings and communicate issues/progress to site and quality leadership. Coordinate and report analytical testing outcomes to support manufacturing and operations activities while ensuring that project objectives are achieved in a timely manner.
• Be a part of sourcing, purchase, installation, startup, calibration, and maintenance of analytical equipment.
• Evaluate, develop, and optimize complex analytical testing methods.
• Remain current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.
• Provide SME support related to QC testing to all business functions at the site.
• Identify and implement process improvement initiatives to meet compliance and create center of excellence.
• The examples of tests include testing for plasmid sequencing, content, plasmid isoform distribution, residual DNA/RNA/host cell proteins, and final plasmid drug substance/drug product release testing.
• Perform OOS/OOT investigations as assigned.
• Drive AD/QC activities to deliver qualifiable and transferable NGS analytical methods to aid the release of plasmid material for clinical and commercial use.
• Work closely with quality assurance, manufacturing, process sciences, and project management teams to provide cross-functional support to meet department, site, and corporate objectives.
• Test raw material, in process, bulk and finished goods samples in accordance with established procedures and using all instrumentation required in the procedures.
  • The examples of tests include testing for plasmid sequencing, content, plasmid isoform distribution, residual DNA/RNA/host cell proteins, and final plasmid drug substance/drug product release testing.
• Manage projects assigned. Able to multi-task efficiently to ensure timely project completion. Maintain efficiency, productivity, and integrity with analytical data to meet required standards.

How will you get here?

Education

• Bachelors in Life Sciences, Engineering, Biochemistry, Biology or related field with 6+ years of relevant industry experience.
• Master’s or Ph.D. with 3+ years of relevant industry experience.

Experience

• Excellent understanding of method development and phase-appropriate validation/qualification per U.S. and EU regulations. Understanding of ICH guidelines and industry standards is preferred.
• Proficiency with analytical and bio-analytical techniques preferred. Techniques include NGS/Sanger Sequencing, qPCR, Capillary Electrophoresis, ELISA, IEX-HPLC, Charged Aerosol Detection, plate-based assays, microbial and sterility assays, and mass spectrometry for both cellular and molecular characterization.
• Excellent problem-solving skills and logical approach to solving scientific problems utilizing QbD principles.
• Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive molecular biology.
• Excellent knowledge and understanding of NGS, preferably with Illumina MiSeq system.

Knowledge, Skills and Abilities

• Proven capability in producing laboratory documentation, reports, and correspondence.
• Self-motivated, with excellent organization skills and detail oriented.
• Proficiency in Microsoft Suite (Word, Excel, PowerPoint, etc.).
• Have flexibility to work various shifts times if needed to meet department or business goals.
• Skilled technical writer, able to convey complex topics through text and diagrams.
• Proficient in use of systems such as LIMS, eDMS, Global TrackWise, SAP (or ERP) preferred.

Physical Requirements / Work Environment

• Location: Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odors, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment is required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.
• Movement: Position requires ordinary ambulatory skills and physical coordination; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Compensation and Benefits

The salary range estimated for this position based in California is $91,700.00-$120,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards