Associate Scientist III, Parenteral Drug Product Development

Biogen; Cambridge (MA); Sur place; USD 77 000 - 100 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Vacation time

Paid holidays

Sick time

Résumé du poste

Biogen is seeking an Associate Scientist III in Parenteral Formulation and Drug Product Development. You will contribute to developing parenteral formulations and DP manufacturing processes to support Biogen’s pipeline, working in a matrix environment with the technical development team.

You will plan and execute experiments, prepare formulations, analyze data, draft development protocols and technical reports for CMC submissions, and maintain GDP-compliant records while collaborating with

Qualifications

• Bachelor’s Degree in a related field with 0-2 years of experience, or a Master’s with 0+ years of experience.
• Experience in a pharmaceutical/biotechnology laboratory environment.
• Experience in formulation development for sterile parenteral drug products.
• Experience performing laboratory experiments, analyzing data, and documenting results using 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.

Responsabilités

• 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 guidance of senior scientists on more complex initiatives.
• Prepare formulations, perform laboratory studies, collect and analyze 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 GDP and support activities in compliance with GLP 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.

Connaissances

Pharma lab experience

Formulation development

GDP documentation

Analytical techniques

Aseptic techniques

Cross-functional teamwork

Communication skills

Formation

Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences

Master's degree

Description du poste

About This Role

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.

About This Role

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.

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.

Who You Are

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.

Job Level: Professional

Additional Information

The base compensation range for this role is: $77,000.00-$100,250.00 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.

Benefits

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.