Director or Associate Director, Formulations
Company: PEAK Technical Staffing USA
Location: San Diego
Posted on: January 26, 2023
Job Description:
Director or Associate Director, Formulations Posted: 01/16/2023
Employment Type: Direct Placement Category: Chemical Job Number:
95935 Job Description Position Objective
This position is for a scientific leader who has broad and deep
expertise in Lipid Nanoparticle (LNP) formulation design and
development. You will be part of the management team and direct a
group of scientists to develop novel lipid nanoparticles for
systemic nucleic acid delivery and cellular targeting.
Compensation
- $150, 000 to $240, 000 AnnuallyBenefits Offered
- 401K, Dental, Life, Medical, VisionEmployment Type
- Full-TimePosition: Director or Associate Director,
Formulations
Reporting To: Vice President, Pharmaceutical Sciences
Core Competencies
- Scientific foundation in a fundamental physical science such as
chemistry or chemical/biomedical engineering or pharmaceutics.
- Understanding of the interface of biology and physical sciences
to develop systems for RNA delivery within mammals.
- Leadership to bridge drug product development activities from
early development (research) though full clinical and commercial
activities.
- Responsibilities
- Serve as the pharmaceutical development representative for
internal and partnered project teams, assuring alignment of work
scope to resources and budget.
- Manage and develop a team of formulation staff that is matrixed
across multiple programs.
- Lead budgeting and staff recruitment and development to ensure
a high performing formulation and drug product development
team.
- Oversee the requisite lipid nanoparticle (LNP) formulation
development work suitable for the intended clinical dosage form
while leveraging and adding to the existing DDS platform knowledge
to be used in early stage or full development programs.
- Design novel lipids, formulations, and delivery concepts
- Assure formulations meet requirement for pharmacology,
preclinical-tox, and clinical development are suitable clinical
dosage forms utilizing the appropriate route of
administration.
- Ensure timeliness and continuity of research and development
drug product supplies with appropriate controls for internal and
partnered programs.
- Knowledge of analytical methods for testing lipid
nanoparticles.
- Expertise in RNA LNP delivery systems incorporating polymers,
conjugates and small molecules.
- Effectively collaborate with chemistry R&D, analytical
R&D, and process R&D to ensure appropriate engagement of
contract manufacturing organizations (CMO) in line with internal
and partner timelines and associated contract facilities.
- Ensure creation of drug product CMC regulatory submission
sections for clinical and commercial applications meeting GMP
compliance to 21CFR part 211 (quality system regulations) for
oligonucleotide and/or mRNA lipid-based drug products.
Education and/or Experience:
- Candidate will possess a Ph.D.in Pharmaceutics, Chemistry,
Chemical or Biomedical Engineering or related field with a minimum
10 years of experience in leading formulations programs for the
biotechnology/pharmaceutical industry.
- At least 5 years' experience in pharmaceutical technical
development disciplines
- At least 3 years of leadership experience at the department
and/or larger team level, including recruiting/coaching high
performing teams and creating/managing program budgets
- Extensive experience designing and developing sterile
parenteral / injectable drug products, including
- Research and development for novel parenteral formulations and
routes of delivery
- Prior experience developing mRNA or oligonucleotides is a
strong plus
- Demonstrated general ability to apply fundamental scientific
and engineering know-how to generate innovative yet practical
solutions to technical challenges.
- Expert at defining and leading cross-functional drug product
development functions from preclinical through commercial launch:
manufacturing, specifications, development studies, stability,
shelf-life, etc.
- Previous experience with writing regulatory submissions is
essential
- Excellent communication and interpersonal skills are
required
- Project management and team leadership skills
Physical Job Requirements:
- Travel 10%
- Mandatory Covid-19 Vaccination Policy in effect
- Office/Lab environment. Lifting up to 20 pounds may be
required. While performing the duties of this job, the employee is
regularly required to use their hands and fingers to operate a
computer keyboard, mouse, and telephone keypad or to write, as well
as talk and hear. They are required to stand, walk or sit, reach
with hands and arms, stoop, kneel, crouch or crawl. Specific vision
abilities required by this job include close vision, distance
vision, peripheral vision, depth perception and ability to
focus.
Disclaimer: The duties and responsibilities of position may change
as need arises. The employee will be notified of the change.
Relevant work experience may also be substituted for education or
certification, at company's discretion.
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Keywords: PEAK Technical Staffing USA, San Diego , Director or Associate Director, Formulations, Executive , San Diego, California
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