Full-Time

Associate Director

Drug Substance Scientist

Confirmed live in the last 24 hours

Biogen

Biogen

10,001+ employees

No salary listed

Senior, Expert

Remote in USA

The position can be based remotely within the United States.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Requirements
  • PhD or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of relevant industry experience
  • Extensive experience in downstream (e.g., chromatography, filtration) drug substance process development for biologics, specifically antibodies
  • Experience with upstream process development is highly preferred
  • Proven track record of successful technology transfers and scale-up to cGMP manufacturing
  • Experience with late-stage process development and regulatory (BLA) submissions
  • Strong knowledge of antibody purification technologies and quality control measures
  • Familiarity with QbD (Quality by Design) principles and risk-based process development
  • Proficiency in data analysis and process modeling tools
  • Strong problem-solving and decision-making skills
  • Excellent communication and collaboration abilities
  • High sense of accountability to deliver results and meet timelines
  • Proven ability to work in a fast-paced, dynamic startup environment
Responsibilities
  • Lead the development, optimization, and scale-up of upstream and downstream processes for antibody drug substance production
  • Collaborate with cross-functional teams to integrate upstream and downstream workflows seamlessly
  • Develop and optimize purification processes, including chromatography, filtration, and other separation technologies for antibodies
  • Establish scalable and robust downstream processes to ensure high yield and purity of drug substance
  • Design, plan, and execute Process Performance Qualification (PPQ) activities to support late-stage upstream and downstream process validation
  • Ensure process robustness and consistency through statistical analysis and data-driven approaches
  • Prepare and review PPQ protocols and reports for regulatory submissions
  • Oversee the transfer of processes to manufacturing facilities, ensuring alignment with regulatory requirements and commercial scalability
  • Work closely with CMOs/CDMOs to support late-stage development and commercialization activities
  • Collaborate with analytical development teams to define critical quality attributes (CQAs) and establish in-process controls
  • Ensure consistency in process performance through data-driven approaches and risk assessments
  • Author and review sections of regulatory filings related to drug substance processes, such as INDs, BLAs, or MAAs
  • Stay up-to-date on regulatory guidelines to ensure compliance in all process development activities
  • Provide technical leadership to the team and mentor junior scientists and engineers
  • Promote a culture of innovation, collaboration, and continuous improvement
Desired Qualifications
  • Experience with upstream process development is highly preferred

Company Size

10,001+

Company Stage

IPO

Headquarters

Cambridge, Massachusetts

Founded

1978

Simplify Jobs

Simplify's Take

What believers are saying

  • FDA approval of Leqembi's maintenance dosing could boost patient adherence and market reach.
  • Biogen's participation in major conferences may increase investor confidence and visibility.
  • Appointment of Adam Feire could lead to new partnerships and innovative growth projects.

What critics are saying

  • Increased competition in Alzheimer's treatments could impact Biogen's market share.
  • Pricing pressures in the U.S. may affect Biogen's profitability.
  • Reliance on Leqembi for growth poses risks if safety issues arise.

What makes Biogen unique

  • Biogen's Leqembi is the only FDA-approved anti-amyloid therapy for Alzheimer's.
  • Biogen's strategic focus on Alzheimer's treatments sets it apart in neurodegenerative therapies.
  • Biogen's collaboration with Eisai enhances its capabilities in personalized medicine for Alzheimer's.

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Benefits

Remote Work Options

Professional Development Budget

Company News

Biogen
Feb 24th, 2025
Biogen to Participate in the TD Cowen 45th Annual Health Care Conference

Cambridge, MA, - - Biogen Inc. (Nasdaq: BIIB) announced today that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in a fireside chat during the TD Cowen 45th Annual Health Care Conference.

Stock Target Advisor
Feb 18th, 2025
Biogen Inc: AI-Powered "Top Pick" with 63% Upside Forecasted

Biogen Inc. has been determined as a "Top Pick" in the biopharma sector due to its strong financial fundamentals, strategic positioning, and promising growth prospects.

PR Newswire
Jan 26th, 2025
Fda Approves Leqembi® (Lecanemab-Irmb) Iv Maintenance Dosing For The Treatment Of Early Alzheimer'S Disease

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapyTOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S

PR Newswire
Jan 14th, 2025
Fda Accepts Leqembi® (Lecanemab-Irmb) Biologics License Application For Subcutaneous Maintenance Dosing For The Treatment Of Early Alzheimer'S Disease

LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option. TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S

PharmiWeb
Jan 10th, 2025
Biogen Appoints Adam Feire As Head Of Business Development And External Innovation

Cambridge, Mass. – January 9, 2025 – Biogen Inc. (Nasdaq: BIIB) – today announced the appointment of Adam Feire, Ph.D., as Head of Business Development and External Innovation. Mr. Feire reports to Adam Keeney, Ph.D., Executive Vice President and Head of Corporate Development. In this role, Mr