Job Description

About This Role

Responsible for supporting the technology transfer process, driving continuous improvement, and managing/authoring all manufacturing technical instructions associated with the different unit operations (batch production records, procedures, work instructions, etc). This position will collaborate with other MTO (Manufacturing Technical Operations) teams across the network to ensure consistency (as applicable) and partner with Quality, Manufacturing, Manufacturing Sciences, Engineering and other functional groups to ensure accuracy and timeliness of documents.

What You'll Do

Plans, leads, and manages all activities withing scope of Manufacturing Technical Operations. Assigning appropriate resources to tech transfers, driving continuous improvement, ensuring manufacturing instructions are clear, safe, and compliant. This position may also manage the batch issuance process/team for manufacturing records and labels and/or the Manufacturing Coordination team for direct operational support.
Effectively lead and coach direct reports to meet career goals and business objectives. Addresses human resource development opportunities and challenges. Actively participates in hiring the best talent and works to develop an exceptional workforce.
Responsible for supporting deviation, CAPA, and GCC closures as needed. Supports inspection readiness efforts. Evaluates, develops, and implements human performance, continuous improvements, and best practices for the group.
Engages in strategic and/or global activities and applies strategies to their department. Participates on a variety of strategy related teams such as CMC, cross-site teams, global practices teams, information technology, regulatory submission teams, and compliance improvement teams.

Qualifications

Required Qualifications:

Bachelor's Degree in Life Sciences or Engineering plus minimum 5 years of experience working in a biotech or pharmaceutical GMP manufacturing environment
OR Associate's Degree plus minimum 7 years of related experience
OR High School Diploma plus minimum 9 years of related experience
Understanding of Quality Systems and direct experience with Change Controls, CAPAs, Investigations
Excellent project management skills
Must be team-oriented (proactively builds healthy working relationships between their department and other groups)
Strong leadership skills and excellent written and oral communication, and presentation skills
Strong strategic thinking skills, having a broad knowledge of GMP operations, QA, QC, Regulatory, and/or Materials Management
Some understanding of finance/budgeting

Preferred Qualifications:

Proven effectiveness in managing employees

Additional Information

The base salary range for this position is $109,000- 146,000 annually. 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 our DE&I efforts.

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.