Biogen

Director, Oral Drug Product Development

Biogen • $188K — $259K *
Cambridge, MA 02139In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field with 12+ years of experience in oral drug product development.
  • Proven track record in formulation and process development for oral solid dosage forms across early and late development stages.
  • Experience with scale-up, technology transfer, and working with external manufacturing organizations.
  • Strong understanding of CMC development, regulatory expectations, and technical documentation.
  • Ability to lead cross-functional teams, influence strategy, manage technical risks, and communicate effectively.

Responsibilities

  • Lead formulation design and process development for small molecule oral dosage forms.
  • Develop enabling formulation strategies for challenging compounds like poorly soluble molecules.
  • Serve as senior drug product representative on cross-functional CMC and asset teams.
  • Influence portfolio decisions through technical risk assessment and developability analysis.
  • Champion technology transfer and clinical manufacturing readiness activities.
  • Mentor and develop junior scientists and engineers in oral drug product development.
  • Oversee preparation of regulatory submissions and related documentation.

Benefits

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including fitness reimbursement
  • Minimum of 15 days of paid vacation plus a year-end shutdown
  • Paid Maternity and Parental Leave
  • 401(k) with company match
  • Tuition reimbursement up to $10,000 per year
  • Employee Resource Groups participation
Full Job Description

About the Role

Biogen is seeking aDirector,Oral Drug ProductDevelopmentto provide scientificand strategicleadershipfor the development of small molecule oral drug products.This role leadsscientificandengineering effortssupportingformulation and process development across early- and late-stage programs.This technicalleadwill driveenabling technologies fortypicallylowsolubilityandlow permeabilitycompounds, clinical manufacturing readiness, technology transfer, and commercialization.The Director serves as a senior drug product leaderandmentoron cross-functional CMC and asset teams, influencing development strategy, manufacturing readiness, and regulatory submissions.This rolewill alsobe responsible formanaging external partnerships andadvancingnew technologiesand workflows that strengthen Biogens oral drug product development capabilities.

WhatYoullDo

  • Leadformulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage formsacross all stages of development.

  • Develop enabling formulation approaches for challenging compounds, including poorly soluble, poorly permeable, unstable, or complex moleculessuch asorallydeliveredpeptides.

  • Serve as the senior drug product representative on cross-functional CMC and asset teams, driving alignment across regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.

  • Influence portfolio decisions through assessment of developability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.

  • Champion technology transfer, clinical manufacturing readiness, and scale-up activities at internal and external manufacturing sites.Provide strategic oversight andestablishmanufacturing strategies.

  • Mentor and developscientists and engineers supporting oral drug product development.

  • Oversee completion of drug product sections for regulatory submissionsandrelatedtechnical documentation.

  • Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.

Who You Are

You are an innovative scientific leader with a passion for advancing drug development processes through rigorous science and data-driven decision-making. You excel at transforming experimental findings into development strategies, using deep technical expertise and sound scientific judgment to solve complex drug product challenges. Your expertise drives you to develop cutting-edge solutions ensuring manufacturability, scalability, and readiness for commercialization. You thrive in collaborative environments, influencing strategic decisions, and fostering alignment across diverse functions. Your mentoring skills inspire teams to achieve excellence, while your forward-thinking approach maximizes Biogens capabilities in oral drug product development.

Required Skills:

  • PhD inPharmaceutical Sciences,Chemical Engineering, Chemistry,or a related scientific disciplinewith a minimum of 12years experience in oraldrug productdevelopment.

  • Demonstratedtrack recordleadingformulation and process development for oral solid dosage forms from early development through clinical manufacturing and/or late-stage development.

  • Experience withscale-up, technology transfer, clinical manufacturing, and external manufacturing organizations.

  • Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase-appropriate development strategies.

  • Provenability to lead across functions,influence program strategy, manage technical risk, and communicate effectively with diverse stakeholders.

  • Experience mentoring, developing, or leadingscientists and engineers.

PreferredSkills:

  • Deepexpertisein enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.

  • Experience with late-stage development, commercial readiness, process characterization, or process validation.

  • Experience supporting at least one NDA/MAA or commercial productand regulatory agency interaction experience.

  • Strong understanding and hands on experience with oral solid dose manufacturing unit operations and manufacturability considerations.

  • Experience implementingnew technologies, digital tools, knowledge platforms, or best practices across multiple programs.

  • Demonstrated success managing external CDMO/CMO relationships and technology transfer activities.


Job Level: Management


Additional Information

The base compensation range for this role is: $188,000.00-$259,000.00


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.


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

About Biogen

Biogen is a biotechnology company engaged in the development of innovative therapies for neurological and neurodegenerative diseases. Biogen is developing a pipeline of possible medicines in neurology, neuropsychiatry, specialized immunology, and rare illness, and the company is laser-focused on its mission of helping humanity through science and building a healthier, more sustainable, and equitable world.

Biogen Careers

Join Biogen, a leader in biotechnology, and be part of a team that is dedicated to pioneering neurological and neurodegenerative diseases research. At Biogen, our mission is to lead the way in science and medicine, and we offer job opportunities that challenge and reward your professional growth. Work You’ll Do At Biogen, you will contribute to groundbreaking projects that help improve the lives of millions. Our commitment to innovation and leadership in the industry provides a dynamic environment for both seasoned professionals and those at the beginning of their career. With a variety of job opportunities ranging from research and development to marketing and sales, Biogen is where your skills will help shape the future of healthcare. Join our diverse team and embrace the culture of excellence and collaboration that Biogen is known for. Here, every position contributes to our mission, driving us forward with shared purpose and vision. Biogen’s Employment Philosophy We believe in the power of our people and invest in their future. The growth and development of our team members are paramount, which is why we offer robust benefits, diversity training, and career advancement opportunities. At Biogen, leadership and innovation go hand in hand, fostering an environment where you can thrive. Internship and Early Career Programs Kickstart your career with a Biogen internship. Gain invaluable industry experience, enhance your resume, and build a professional network that will serve you throughout your career. Our internships provide a platform to develop your skills and test your knowledge in a real-world setting, preparing you for full-time employment in the biotechnology field. Hiring Process Our hiring process is designed to identify and attract professionals who are passionate about making a difference. From the initial application and resume submission to the interview and final selection, each step is an opportunity to showcase your unique talents and potential. At Biogen, we look for individuals who are curious, creative, and eager to tackle new challenges. Stay Connected Join Our Team Explore the various positions available at Biogen and find the one that best matches your skills and interests. We are constantly looking for individuals who are driven to explore, innovate, and lead. Keep Up to Date Stay informed with the latest career tips, insider perspectives, and industry-leading insights—all from the people who work here. Biogen is not just a company; it’s a community where you can grow, connect, and contribute to exciting, meaningful work. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the rewarding opportunities waiting for you at Biogen and be part of our mission to lead in the biotechnology industry. Join Biogen today and be part of a team that is dedicated to redefining the boundaries of science and medicine. Your career at Biogen is not just a job—it’s a pathway to personal and professional fulfillment.
Learn more about Biogen
Size
9,610 employees
Market Cap
$39.7 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4 billion
Founded
1978
5 Year Trend
-0.8%
Revenue
$13.4 billion
NASDAQ
BIIB
* Ladders Estimates

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