The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate ...
The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate ...
Associate Director/Director Drug Product and Formulation Development At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic ...
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Associate Director/Director Drug Product and Formulation Development At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic ...
Description Associate Director/Director Drug Product and Formulation Development At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target ...
Description Associate Director/Director Drug Product and Formulation Development At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target ...
Director, Drug Product Formulations
Boston, MA · On-site
$253K - $265K/yr
Oversee drug product design and development from pre-formulation through clinical and commercial ... Direct process development, scale-up, and manufacturing of oral dosage forms (e.g., blending ...
Quick apply
Director, Drug Product Formulations
Boston, MA · On-site
$253K - $265K/yr
Oversee drug product design and development from pre-formulation through clinical and commercial ... Direct process development, scale-up, and manufacturing of oral dosage forms (e.g., blending ...
Director, Drug Product Formulations
Boston, MA · On-site
$253K - $265K/yr
Oversee drug product design and development from pre-formulation through clinical and commercial ... Direct process development, scale-up, and manufacturing of oral dosage forms (e.g., blending ...
Director, Drug Product Formulations
Boston, MA · On-site
$253K - $265K/yr
Oversee drug product design and development from pre-formulation through clinical and commercial ... Direct process development, scale-up, and manufacturing of oral dosage forms (e.g., blending ...
A successful candidate should have a thorough understanding of formulation development and fill ... Lead the Drug Product Development team activities for multiple products, including new product ...
A successful candidate should have a thorough understanding of formulation development and fill ... Lead the Drug Product Development team activities for multiple products, including new product ...
Associate Director, Formulation and Drug Product Development
Waltham, MA · On-site
$159K - $195K/yr
The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate ...
Associate Director, Formulation and Drug Product Development
Waltham, MA · On-site
$159K - $195K/yr
The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate ...
Drug product formulation, delivery, and process development activities in support of AAV gene therapy research in a small-scale manufacturing facility * Utilize biophysical characterization ...
Drug product formulation, delivery, and process development activities in support of AAV gene therapy research in a small-scale manufacturing facility * Utilize biophysical characterization ...
Drug product formulation, delivery, and process development activities in support of AAV gene therapy research in a small-scale manufacturing facility * Utilize biophysical characterization ...
Drug product formulation, delivery, and process development activities in support of AAV gene therapy research in a small-scale manufacturing facility * Utilize biophysical characterization ...
Job Summary: The Director, CMC Product Development - Biologics is a senior technical and ... Define and execute the biologics drug product development strategy, encompassing formulation ...
Job Summary: The Director, CMC Product Development - Biologics is a senior technical and ... Define and execute the biologics drug product development strategy, encompassing formulation ...
Job Summary: The Director, CMC Product Development - Biologics is a senior technical and ... Define and execute the biologics drug product development strategy, encompassing formulation ...
Job Summary: The Director, CMC Product Development - Biologics is a senior technical and ... Define and execute the biologics drug product development strategy, encompassing formulation ...
Design and independently execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support drug product development for early ...
Design and independently execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support drug product development for early ...
Design and independently execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support drug product development for early ...
Design and independently execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support drug product development for early ...
Senior Associate Scientist - Biologics Formulation & Drug Product Development
Indianapolis, IN · On-site
About the Role As a Senior Scientist in Biologics Formulation & Drug Product Development team, you ... Direct experience with multiple dosage forms and presentations (e.g., sterile injectables ...
Senior Associate Scientist - Biologics Formulation & Drug Product Development
Indianapolis, IN · On-site
About the Role As a Senior Scientist in Biologics Formulation & Drug Product Development team, you ... Direct experience with multiple dosage forms and presentations (e.g., sterile injectables ...
The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory ...
The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory ...
Director, Pharmaceutical Development
Aliso Viejo, CA · On-site
$225K - $250K/yr
The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory ...
Director, Pharmaceutical Development
Aliso Viejo, CA · On-site
$225K - $250K/yr
The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory ...
The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory ...
Quick apply
The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory ...
Reporting into our Senior Director, Drug Product- this person will lead formulation design and optimization, oversee studies related to product quality and stability, and support development ...
Reporting into our Senior Director, Drug Product- this person will lead formulation design and optimization, oversee studies related to product quality and stability, and support development ...
Senior Scientist II - Biologics Drug Product Development
North Chicago, IL · On-site
$109K/yr
We are seeking an accomplished scientist with a proven track record in biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM) . This position ...
Senior Scientist II - Biologics Drug Product Development
North Chicago, IL · On-site
$109K/yr
We are seeking an accomplished scientist with a proven track record in biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM) . This position ...
We are seeking an accomplished scientist with a proven track record in biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM) . This position ...
We are seeking an accomplished scientist with a proven track record in biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM) . This position ...
Director Drug Product Formulation Development information
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$73K - $88.6K
3% of jobs
$88.6K - $104.2K
3% of jobs
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8% of jobs
$130.9K is the 25th percentile. Wages below this are outliers.
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15% of jobs
The median wage is $158.2K / yr.
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14% of jobs
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11% of jobs
$188K is the 75th percentile. Wages above this are outliers.
$182.1K - $197.7K
17% of jobs
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5% of jobs
$213.3K - $228.9K
4% of jobs
$228.9K - $244.5K
5% of jobs
$73K
$163.7K
$244.5K
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Posted 28 days ago
Job description
Role Summary:
The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne's strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials.
This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.
Primary Responsibilities Include:
- Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing.
- Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts.
- Build and enhance internal capabilities for formulation development in the laboratory.
- Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3).
- Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
- Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation.
- Responsible for driving execution of the formulation development plan at CDMO (PO through delivery).
- Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration.
Education and Skills Requirements:
- PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.Â
- Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
- Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities.
- Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.
- Strong experience and knowledge of cGMP manufacturing requirements.
- Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
- Experience managing complex schedules and priorities in a dynamic biotech environment.
- Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs).
- Collaborative work style to be part of a team to identify process gaps and constructively develop solutions.
- Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships.
- Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.
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About Dyne Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
Waltham, MA, US
Year founded
2017