Associate Director/Director Manufacturing - GMP
- Employer
- ReCode Therapeutics
- Location
- Menlo Park, California
- Start date
- Sep 28, 2022
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Who We Are:
We are an integrated genetic medicines company developing targeted, disease-modifying medicines for patients with life-limiting respiratory diseases. Our treatments address the underlying genetic cause in underserved populations and have the potential to tremendously impact the quality and length of patients’ lives.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission: harnessing our multi-platform approach to develop disease-modifying medicines. Our team is uniquely positioned to tackle this challenge, given our extensive experience in RNA delivery technologies, protein structure, tRNA biology, mRNA manufacturing, gene editing, and drug development.
Summary of Position:
The responsibilities of this role will be to establish scale up and manufacture lipid nanoparticles (LNPs)-RNA parenteral drug products. In addition, the incumbent will be expected to oversee qualification of cleanroom environment and establish systems in the department to enable manufacture of the batches for GLP toxicology and clinical studies under GMP. Also, in this role the candidate will work within cross-functional product development team including Formulation Development, mRNA Process Development, Analytical Development, Clinical Ops., Reg. Affairs and Quality in development and commercialization of gene therapy drug products.
Responsibilities:
- Provide leadership in scale up and manufacture LNPs-RNAs developmental drug products.
- Provide expertise and oversee equipment design for scale up LNPs-mRNA production to required scales
- Provide science-based approach to upstream process, purification steps characterization and optimization, determine the effect of process parameters, reagents and equipment used on product yield and critical quality attributes.
- Establish robust unit operations and verify process design space to define process control strategies that facilitate the commercial scale manufacture
- Establish required quality systems, SOP and batch records to manufacture drug products when needed for GLP toxicology and clinical studies
- Participate in preparation of appropriate eCTD sections for regulatory submissions
- Responsible for managing a department, hire, train and coach staff.
- Summarize and present data, author development reports and provide recommendations to product development teams
- Some hands-on work in the lab is expected
Qualifications:
- Minimal qualifications: Ph.D. 5+ or MS 10+ years of experience in chemical engineering, bioengineering, chemistry, or a related discipline.
- Previous experience (5+ years) in developing and scaling drug product formulation and fill finish processes.
- GMP manufacturing experience
- Experience with lipid nanoparticle formulations, tangential flow filtration technologies, and the scaling of mixing operations.
- Process development of liposomal, LNPs, or similar lipid-based drug products
- Extensive knowledge of GMP and regulatory CMC.
As a bonus
- Knowledge of lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules.
- Proficiency with Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis.
- Strong collaborator with cross-functional teams and external partners
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.
Company
The Why Behind Our Work
We imagine a world where people living with genetic diseases can fully benefit from the promise of genetic medicines. Our novel mRNA and gene correction therapeutics have the potential to make this a reality.
Therapeutic Areas of Focus
Cystic fibrosis
Primary ciliary dyskinesia
Certain cancers and central nervous system (CNS) diseases
Power the Next Wave of Genetic Medicine
We are one of the rare companies whose innovations are poised to fundamentally shift an entire class of medicine.
Join us as we advance our pipeline into clinical development and scale ReCode’s next-generation genetic medicines delivery platform and pipeline.
- Website
- https://recodetx.com/
- Phone
- 408-585-1700
- Location
-
1140 O'Brien Drive
Menlo Park, CA 94025
US
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