FSP – Sr. Scientist – Biologics Drug Product Development Full-time

Pharmaceutical Development Scientist

Work Schedule Standard (Mon-Fri)

Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key Responsibilities:

We are seeking a highly motivated scientist to join our Pharmaceutical Development team. This role will be expected to work as a key lab work contributor and focus on building lab capability for biologics drug product development and occasionally supporting pre-clinical and clinical phase development studies for a diverse portfolio of therapeutic biologics modalities. The successful candidate will be able to adapt quickly to a highly collaborative and fast-paced team environment, flexibly supporting multiple development projects. Key areas of focus include supporting instrument setup and phase appropriate formulation and drug product process development; biologics molecule characterization and analysis using state of art bioanalytical methods and equipment including but not limited to UPLC or HPLC (SEC, RP, HIC, IEX/CEX, CAD preferred), charge variants analysis, particle analysis, CE-SDS, and other physical property characterizations. Experience in LC and iCIEF is a must.

• Serve as a key contributor in the setup, operation, maintenance, and troubleshooting of instruments, in method development, and in the authoring of related reports, SOPs, and best practices.
• Collaborate effectively within a team setting to lead the design, execution, and documentation of internal experimental studies to support phase-appropriate drug product development and clinical material production.
• Draft comprehensive development reports, memos, and other scientific documentation throughout the development process.
• Engage in cross-functional collaboration with project management, quality assurance, analytical, R&D, and non-clinical teams to facilitate development work and support manufacturing campaigns.
• Communicate development progress, timelines, and study results to the manager, ensuring transparency and alignment with project goals.
• Perform physicochemical and bioanalytical characterization and testing using state-of-the-art analytical instrumentation and techniques.
• Prepare solvents, standards, buffers, and other solutions, ensuring proper weighing, record-keeping, and adherence to safety protocols
• Collaborate with and assist other lab scientists in preparing samples and performing other lab support tasks
• Manage documentation for study planning and organization, maintain a laboratory notebook, laboratory inventory, and instrument maintenance schedules.

Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
• OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• In-depth understanding of bio-chemical and physical properties of therapeutic biologics including but not limited to proteins and viral particles. Possesses basic knowledge of protein quantification and characterization methods.
• Experience in developing and optimizing methods to characterize protein or virus biologics molecules and understanding the pharmaceutical properties of drug products and formulations.
• Hands-on experience in commonly used characterization and analytical instruments for a biologics drug product lab; A good understanding of the principles of those instruments and assays; ability to independently troubleshoot minor instrument issues.
• Ability to interpret testing results, identify trends and out-of-trend data points, summarize findings, and make scientific conclusions
• Excellent at technical writing: ability to draft SOPs, best practices, technical reports, or similar documentation
• Ability to participate in the design and independently perform early-phase formulation studies for biological drug candidates.
• Understand fundamentals and hands-on experience with aseptic processes for the fill-finish of sterile parenteral biological drugs
• Understanding of the basics of GXP compliance and practices for biological drug products is a plus
• Strong organizational and technical problem-solving abilities
• Experience supporting pharmaceutical product development and transfers to clinical manufacturing is a plus
• Ability to effectively prioritize tasks and manage multiple projects
• Acts as a team player and collaborator who can listen effectively and communicate in an open, clear and timely manner
• Well-trained in Good Documentation Practices (GDP) within the pharmaceutical industry
• Develops knowledge of scientific principles, methods, and techniques

Solid knowledge and experience working with bioanalytical laboratories to ensure safety compliance

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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!

Compensation and Benefits The salary range estimated for this position based in California is $90,027.00–$96,953.00. 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:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• 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
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount