Senior Scientist, Parenteral Drug Product Development

Biogen•Cambridge, MA

About The Position

Biogen is presently looking to fill a Senior Scientist 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.

Requirements

Demonstrated experience with sterile drug product development and parenteral formulations preferably with hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics.
Strong understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
Prior experience working in a biopharmaceutical product development environment or working with CDMOs and familiarity with GMP guidelines.
Experience conducting technical risk assessments using quality-by-design principles.
Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions including IND, IMPD, NDA and responses to health authority’s questions.
Experience in analytical and characterization techniques used for characterization of sterile drug products.
Demonstrated ability to independently lead technical initiatives, solve complex scientific problems, and effectively collaborate across multidisciplinary teams.

Nice To Haves

Experience with formulation development of proteins, antibodies, antibody-drug conjugates, or other complex biologics 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.

Responsibilities

Design and execute formulation and process development studies supporting preclinical, clinical, and commercial drug product development.
Lead 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, PPQ, and commercial manufacturing.
Lead studies supporting process characterization, process validation, manufacturing robustness, and lifecycle management.
Collaborate closely with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations.
Develop scientifically sound strategies for primary container closure systems, including vials, prefilled syringes, and other advanced delivery systems.
Support selection, qualification, and compatibility assessment of manufacturing equipment, single-use systems, filters, and container closure systems.
Prepare and coordinate drug product supply for nonclinical and clinical studies.
Author technical reports, development protocols, validation protocols, regulatory submission documents, responses to health authority questions and contribute to global regulatory submissions.

Benefits

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