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Sr Associate
Job Description
*Depending on experience
This role in Pivotal Drug Product Technologies will be to provide support of drug product formulation and process development of biologics. The candidate will work closely with a team of engineers and scientists responsible for the technical aspects of drug product commercialization and lifecycle management.
Responsibilities will include:
• Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.
o Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
o Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization, particle quantitation/characterization, physical properties, etc.
• Data analysis and documentation/review in electronic notebooks.
• Author, review, and data verify technical documents such as protocols, reports, regulatory documents, etc.
• Clearly and consistently communicate data in progress reports and presentations.
• Participate in cross-functional teams in a fast-paced environment to progress product development.
• Adhere to all training, compliance, and safety guidance.
• Support lab operations and inspections as required of all lab-based staff.
• Work primarily onsite with remote work as appropriate to role and tasks.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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