Scientist I, Parenteral Drug Product Development

Biogen, Inc.; Cambridge (MA); On-site; USD 103,000 - 134,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness reimbursement

Paid vacation and holidays

401(k) matching

Job summary

Biogen, Inc. is seeking a Scientist I/II to join the Parenteral Formulation and Drug Product Development group.

The role focuses on designing and executing formulation and process development studies for parenteral drug products across preclinical to clinical stages. The candidate will collaborate with multiple functions to support manufacturing campaigns, technology transfer, and regulatory submissions, while contributing to device and container closure system evaluations and nonclinical drug

Qualifications

• Demonstrated experience with pharmaceutical drug product development, preferably sterile drug product development and parenteral formulations.
• Hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics is preferred.
• Understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Experience planning and executing laboratory experiments, analyzing data, and drawing scientifically sound conclusions.
• Experience with analytical and characterization techniques used for sterile drug products.
• Experience authoring technical reports, protocols, and other CMC documentation; exposure to regulatory submissions such as IND, IMPD, or NDA is preferred.
• Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions.
• Experience in analytical and characterization techniques used for characterization of sterile drug products.
• Demonstrated ability to work independently on assigned technical activities, solve scientific problems, and effectively collaborate across multidisciplinary teams.

Responsibilities

• Design and execute formulation and process development studies supporting preclinical and clinical drug product development, with opportunities to support commercial development activities.
• Contribute to development of sterile parenteral drug products, including formulation optimization, manufacturing process development, and technology transfer.
• Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.
• Execute studies supporting formulation and process optimization, product and process characterization, and manufacturing robustness.
• Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations to support program objectives.
• Support development and evaluation of primary container closure systems, including vials, prefilled syringes, and other delivery systems.
• Support evaluation of manufacturing equipment, single-use systems and filters for drug product development and manufacturing.
• Prepare and coordinate drug product supply for nonclinical studies.
• Author technical reports, development protocols, and other CMC documentation supporting regulatory submissions.

Skills

Parenteral formulation

Sterile formulation

Aseptic filling

Process development

Analytical techniques

Team collaboration

Regulatory submissions

Independent work

PPQ/tech transfer

Education

Ph.D. in Chemical Engineering

M.S. in related field

B.S. with relevant experience

Job description

About This Role

Biogen is presently looking to fill a Scientist I/II position within its Parenteral Formulation and Drug Product Development group. The candidate will be responsible for formulation and process development activities of parenteral drug product programs to support Biogen’s growing pipeline. Candidate is expected to work collaboratively in a matrix environment with other members of the technical development team. The candidate must be motivated and innovative with exceptional analytical and communication skills.

What You’ll Do

• Design and execute formulation and process development studies supporting preclinical and clinical drug product development, with opportunities to support commercial development activities.
• Contribute to development of sterile parenteral drug products, including formulation optimization, manufacturing process development, and technology transfer.
• Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.
• Execute studies supporting formulation and process optimization, product and process characterization, and manufacturing robustness.
• Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations to support program objectives.
• Support development and evaluation of primary container closure systems, including vials, prefilled syringes, and other delivery systems.
• Support evaluation of manufacturing equipment, single-use systems and filters for drug product development and manufacturing.
• Prepare and coordinate drug product supply for nonclinical studies.
• Author technical reports, development protocols, and other CMC documentation supporting regulatory submissions.

Qualifications Who You Are

You have general knowledge of parenteral drug product development and manufacturing. You will be part of a dynamic drug product development group consisting of scientists and engineers. You will be working closely with the Pharma Process Development and Regulatory CMC team as well as R&D, Manufacturing and Quality teams to support development activities of Biogen oligonucleotide programs. You have passion for learning and proactive attitude to drive success in your new role. You enjoy and thrive in a fast-paced team/matrix environment as well as working independently to manage priorities and maintain project timeline. Your dedication to excellence and your ability to adapt to a dynamic, matrixed organization will be key assets in achieving our collective goals.

Education Requirements

Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Analytical Chemistry or related fields with 0 - 4 years experience in pharmaceutical or biotech settings. OR M.S. degree with 2 to 4+ years of relevant experience OR B.S. degree with 4 to 6+ years of relevant experience

Required Skills

• Demonstrated experience with pharmaceutical drug product development, preferably sterile drug product development and parenteral formulations.
• Hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics is preferred.
• Understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Experience planning and executing laboratory experiments, analyzing data, and drawing scientifically sound conclusions.
• Experience with analytical and characterization techniques used for sterile drug products.
• Experience authoring technical reports, protocols, and other CMC documentation; exposure to regulatory submissions such as IND, IMPD, or NDA is preferred.
• Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions.
• Experience in analytical and characterization techniques used for characterization of sterile drug products.
• Demonstrated ability to work independently on assigned technical activities, solve scientific problems, and effectively collaborate across multidisciplinary teams.

Preferred Skills

• Experience formulating biologics, including high-concentration protein formulations is a plus.
• Experience supporting technology transfer, engineering batches, process validation, or PPQ activities is highly desirable.
• Experience in developing and analyzing drug delivery systems and targeted conjugate molecules is a plus.
• Knowledge of statistical software, design or experiment programming and general visualization of sophisticated data sets is a plus.

Job Level

Professional

Additional Information

The base compensation range for this role is: $103,000.00-$133,750.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.