Associate Scientist III, Parenteral Drug Product Development
Biogen
Summary
Biogen is presently looking to fill an Associate Scientist III position within its Parenteral Formulation and Drug Product Development group. The candidate will contribute in the development of parenteral formulations and drug product manufacturing (DP) processes 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.
Job description
What You'll Do
- Plan and execute laboratory experiments supporting formulation development, product characterization, process development and evaluation of new technologies.
- Independently manage assigned development activities while working under the guidance of senior scientists on more complex technical initiatives.
- Prepare formulations, perform laboratory studies, collect and analyze experimental data, and communicate findings to project teams.
- Author development protocols, perform data analysis, prepare technical reports, and documentation for support of CMC submissions.
- Maintain accurate laboratory records in accordance with Good Documentation Practices (GDP) and support activities in compliance with GLP requirements, as applicable.
- Collaborate with cross-functional partners including Analytical Development, Drug Substance Development, Manufacturing Sciences, Quality, Device Engineering, and Regulatory to support project objectives.
- Contribute to continuous improvement initiatives, laboratory organization, and implementation of new technologies.
Qualifications
You are an enthusiastic scientist eager to expand your technical expertise in drug product development. 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 to support development activities of Biogen parenteral programs. You enjoy collaborating with others, are proactive in learning new techniques, and thrive in a dynamic, team-oriented environment where you can contribute to the success of innovative therapeutic programs. 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
The candidate will minimally have a Bachelor's Degree in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field with 0 - 2 years' of relevant industry experience, or a Master's Degree with 0+ years of relevant industry experience.
Required Skills
- Experience working in a pharmaceutical or biotechnology laboratory environment.
- Familiarity with formulation development for pharmaceutical products, preferably sterile parenteral drug products.
- Experience performing laboratory experiments, analyzing experimental data, and documenting results using Good Documentation Practices (GDP).
- Working knowledge of laboratory instrumentation and analytical techniques used for characterization of drug products.
- Familiarity with sterile laboratory practices and aseptic techniques is preferred.
- Strong organizational skills with the ability to manage multiple assignments simultaneously.
- Excellent written and verbal communication skills and the ability to work effectively within cross-functional teams.
Preferred Skills
- Experience with sterile injectable drug product development.
- Experience working with oligonucleotide, peptide, biologic, antibody, or conjugated therapeutics.
- Familiarity with formulation characterization techniques including chromatography, particle analysis, spectroscopy, and physicochemical characterization.
- Experience with Design of Experiments (DoE), JMP, Minitab, or other statistical analysis software is a plus.
Requirements
- Bachelor's Degree in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field with 0 - 2 years' of relevant industry experience, or a Master's Degree with 0+ years of relevant industry experience
- Experience working in a pharmaceutical or biotechnology laboratory environment
- Familiarity with formulation development for pharmaceutical products, preferably sterile parenteral drug products
- Experience performing laboratory experiments, analyzing experimental data, and documenting results using Good Documentation Practices (GDP)
- Working knowledge of laboratory instrumentation and analytical techniques used for characterization of drug products
- Strong organizational skills with the ability to manage multiple assignments simultaneously
- Excellent written and verbal communication skills and the ability to work effectively within cross-functional teams
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short-Term Disability
- Long-Term Disability
- Paid Vacation
- Paid Holidays
- Paid Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.