Description:

The Senior Scientist / Scientist II will be hands-on in the laboratory, performing various tests and experiments to ensure the scientific integrity and success of product development, qualification, unknown peak identification, degradation pathway analysis via stress studies, reference standard qualification, comparability studies, release and stability testing in GMP setting. The position will contribute to the strategy of selecting and implementing the assays to ensure the products are well characterized and under quality control guidelines. Additionally, the role requires building collaborative relationships, staying updated with industry trends, leading the team in decision-making and problem-solving processes and being able to achieve department goals.

Responsibilities

• Utilize experience directly working for a related biotechnology industry company to contribute to the analytical development and quality control team

• Develop and apply molecular biological methods, and other state of the art analytical technologies to analyze and characterize products, their conjugates, and variants

• Proven ability to work successfully in cross-functional teams and represent at various internal and external meetings

• Strong background in implementing phase-appropriate assays for various analytical methods such as SEC, RP-HPLC, HILIC, IEX, CE-SDS, cIEF as well as ELISA and qPCR

• Experience in developing and performing Liquid Chromatography-Mass Spectrometry (LC-MS) based methods to be used for characterization and/or GMP quality control of therapeutic proteins

• Experience in cell biology (cell based assay) and immunology, with application to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities

• Proficient in analytical method development, qualifying assays and validation

• Routinely execute and review analytical assays for release of drug substance, drug product, in process, and stability in GMP setting

• Author/review deviations, SOPs, batch records, CAPAs, OOSs

• Experience in drafting analytical sections of INDs

• Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting

• Demonstrate excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization

• Guide and train team members and serve as the subject matter expert in physicochemical and biological assays

• Knowledge of compendial assays is preferred

• Experience in mentoring and scientific leadership is preferred

Additional Skills & Qualifications:

• Prior experience working directly for a Biotechnology or Biopharmaceutical company within a similar capacity required

• BS with 5-8 years of hands-on industry experience in developing and routinely executing physicochemical and biological assays using variety of analytical instruments including HPLC/UPLC

• MS with 4-6 of hands-on industry experience in developing and routinely executing physicochemical and biological assays using variety of analytical instruments including HPLC/UPLC

• Prior experience performing quality audits and OOSs strongly preferred

Education

• Bachelor’s degree in the life sciences, biochemistry, or related field is required

• Master’s degree in life science, biochemistry or a related field is preferred

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.