R&D/Mfg Scientist III

2 weeks ago

Greenville, South Carolina, United States Thermo Fisher Scientific Full time

Work Schedule

Other

Environmental Conditions

Office

Job Description

COMPANY INFORMATION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

You will enable our customers to make the world healthier and safer by taking part in the method validation and transfer activities at our facility. You will perform all your testing/documentation tasks according to the highest quality standards and according to the governing standard operating procedures, regulatory expectations and compendial requirements. The mission of the Analytical Development Laboratory is to ensure that all test methods required to release the Drug Product at our facility are robust, compliant, and ready in a timely manner to support our clients filling and commitment to the patients.

Key Responsibilities:

  • Conducts high level critically complex chemical and physical testing of pharmaceutical raw materials, incoming materials, finished products, and stability samples using internally developed and validated methods, methods transferred from clients, and/or Compendial methods.
  • Lead and participate in the validation and/or transfer of test methods for raw materials and finished drug products. Drug products include small molecules and biologics such as vaccines, proteins, monoclonal antibodies, and others.
  • Preform testing using HPLC, GC, spectroscopy, LC/MS, ICP, CE/SDS, icIEF, SDS-PAGE, ELISA, diverse immunoassays, and wet chemistry techniques.
  • Support method development and optimization for product testing and manufacturing processes development and optimization.
  • Maintain and troubleshoot analytical instrumentation as needed.
  • Drive initiation and closures of different quality records (deviations, change control, OOS, CAPA).
  • Draft and review GMP documents such as SOPs, Analytical Protocols, Analytical Reports, specifications, and testing documents.
  • Lead projects without supervision; may lead multiple projects, including managing projects timelines and deliverables.
  • Participate (and lead if needed) meetings/teleconferences with clients. Coordinate method development/validation/transfer activities delivering work that meets and exceeds clients' expectations.
  • Train junior staff and support clients and regulatory agencies audits.
  • Perform all duties in strict compliance with SOPs, GMP, GLP and Safety guidelines.

Qualifications:

  • Minimum BS/BA with a concentration in Chemical or Biological Science or related discipline with 5+ years related experience, or
  • Master's degree, 3+ year related pharmaceutical experience is strongly preferred.
  • Proficient with HPLC, GC, LC/MS, ICP, CE/SDS, ELISA, icIEF techniques.
  • Must be experienced and have a thorough understanding of GMP testing requirements.
  • Must have an extensive experience with analytical methods development and validation, and highly skilled in analytical methods troubleshooting.
  • Must have experience with technical writing-method validation protocols and reports, testing documents.
  • Experience with EMPOWER required.
  • Exceptional analytical capability and problem-solving skills.
  • Ability to work in a team atmosphere and influence others to achieve results.
  • Self-motivated with bias for action.
  • Strong communication skills, written and oral.
  • Excellent interpersonal and persuasive communications abilities.
  • Outstanding follow up and organizational/planning skills.
  • Strong attention to details and ability to multitask.
  • Demonstrate the Thermo Fisher values (The Four I's) – Integrity, Intensity, Innovation, and Involvement

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. 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 pound 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. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

BENEFITS

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today

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.

Accessibility/disability access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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