Manager/Senior Manager, Pharmaceutics and Drug Product

Relay-Therapeutics; Cambridge (MA); On-site; USD 122,000 - 174,000; Full time

Job summary

Relay Therapeutics in Cambridge, MA is seeking a Manager/Senior Manager for Pharmaceutics and Drug Product to lead formulation development for preclinical and early clinical programs. You will design discovery formulations, conduct pre-formulation and stability studies, and coordinate with DMPK, toxicology and analytics to ensure timely manufacturing and study supply.

You will collaborate with cross-functional teams across science disciplines, drive developability assessments, and supervise

Qualifications

• Master’s or advanced degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 6+ years of relevant experience in early-stage formulation development for small molecules with a focus on developing oral dosage forms.
• Hands-on experience with preclinical and clinical formulations using solutions, suspensions, emulsions, tablets and capsules.
• Experience with poorly soluble compounds using solid dispersions, nano-suspensions, lipid formulations and particle size reduction.
• Thorough understanding of analytical techniques such as HPLC, UPLC, UV-Vis, IR, PXRD, DSC/TGA, DVS, GC, KF, particle size analysis, SEM.
• Strong knowledge of pharmaceutics principles and developability risk assessment.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and manage formulation development activities for pre-clinical research and early clinical programs.
• Design and develop discovery formulations to enable biology, pharmacology, and animal PK/tox assessments.
• Plan pre-formulation and formulation studies for initial clinical formulation and IND filing.
• Conduct stability studies to support advancement of discovery compounds.
• Coordinate with drug substance, DMPK, toxicology and analytics to ensure supply for DRF and GLP studies.
• Collaborate with discovery groups to develop formulation protocols for their studies.
• Plan manufacturing, testing, and analysis of pre-clinical and early-stage formulations at CROs/CDMOs.
• Present data in technical meetings and provide recommendations on formulation challenges.
• Design and execute polymorph and salt screening to select suitable form.

Skills

Formulation development

Oral dosage forms

Preclinical formulation studies

Early-stage formulation experience

Analytical thinking

Cross-functional collaboration

Education

Master’s or advanced degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry or related fields

Tools

HPLC

UPLC

UV-Vis

IR

PXRD

DSC/TGA

DVS

GC

KF

Particle size analysis

SEM

Job description

Manager/Senior Manager, Pharmaceutics and Drug Product

Cambridge, MA

The Opportunity:

• You will be an integral part of Relay’s drug product development team supporting Relay's research and development programs.
• You will be responsible for design and development of pre-clinical formulations to support discovery research and enable candidate selection/nomination.
• You will be responsible for collaborating with biology, medicinal chemistry, DMPK, and toxicology to execute scientific studies of discovery compounds in alignment with technical goals of the program
• You will be responsible for developing phase-appropriate oral drug product formulations and manufacturing process to enable early-stage clinical studies.

Your Role:

• You will lead and manage formulation development activities to support pre-clinical research and early clinical stage programs independently,
• You will design and develop fit-for-purpose discovery formulations of investigational compounds to enable required scientific (biology, pharmacology, animal PK/Tox etc.) assessments.
• You will design and execute pre-formulation and formulation development studies to support initial clinical formulation and IND filing.
• You will conduct in-use and R&D stability studies (chemical, physical, thermal and photo-stability) to support advancement of discovery compounds
• You will coordinate with drug substance, DMPK, toxicology and analytical, to ensure timely manufacture, release and supply of formulations to support dose range finding (DRF) and GLP studies.
• You will collaborate with drug discovery groups (Medicinal Chemistry, Biology, DMPK, Toxicology) to develop formulation protocols for their respective studies including DRF and GLP studies.
• You will design, develop and execute plans for manufacturing, testing, and analysis of pre-clinical and early-stage clinical formulations/drug products at CRO's/CDMO's.
• You will collate, interpret and present scientific data in technical meetings and provide guidance/recommendations on topics and technical challenges, as applicable, related to formulation/drug product development
• You will design and execute polymorph and salt screening studies for selected candidate compounds and recommend most suitable form for pharmaceutical development
• You will perform developability risk assessment of investigational compounds selected for clinical development
• You will monitor, evaluate completion of tasks and projects, present summaries/updates to management.

Your Background:

• Master’s or advanced degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 6+ years of relevant experience in early-stage formulation development for small molecules with a focus on developing oral dosage forms.
• Hands on experience with fit-for-purpose preclinical and clinical formulations using traditional methods such as solutions, suspensions, emulsions, tablets and capsules.
• Hands on experience in formulation development of poorly soluble compounds using various approaches such as solid dispersions, nano-suspensions, lipid formulations and particle size reduction techniques.
• Hands on experience and thorough understanding of analytical techniques such as HPLC, UPLC, UV-visible, IR, PXRD, DSC/TGA, DVS, GC, KF, particle size analysis, SEM etc.
• Strong understanding of pharmaceutics, including physicochemical properties/profiling of compounds, pharmacokinetics and biopharmaceutics principles and their application to drug product formulation development.
• Experience with PBPK modeling, in silico models is a plus
• Ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Exceptional attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
• Proven ability to collaborate effectvely across internal and external stakeholders.
• Excellent written and verbal communication skills with strong problem-solving capabilities.

Estimated Salary Range: [ $122,000 - $174,000 ]

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal partsfearlessandrelentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

As set forth in Relay Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval, or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval, or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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