Formulation Expert
Vor 2 Tagen
Join our client in this
12 month contract
within Pharmaceutical & Analytical Development (PHAD) and be a part of cutting-edge parenteral drug product development. Contribute to the advancement of novel technology platforms such as Oligonucleotides and Radioligand Therapies (RLT).
Major accountabilities:
- Accountable for all formulation and manufacturing process deliverabl
es including scientific documentation, design of experiments of parenteral products, batch records, deviations, change controls, CAPAs, tech transfer, and reports - Drive DP development, manufacturing process transfers and supply activities
with scientific and technological excellence - Work closely with cross functional teams both internal and external to provide technical input for the development and manufacturing process (including CRO and CMOs).
- Provide technical support to compile technical regulatory documentation
and responses to regulatory agencies as needed. - Assist with writing and reviewing of CMC documentation
associated with project or manufacturing changes.
Key Skills:
- E
xperienced in developing injectable drugs, including solutions, suspensions, and aseptic formulations - Knowledge
of RNA-based therapies (e.g., siRNA, mRNA) and drug delivery systems like pre-filled syringes or vials - Skills in designing manufacturing processes and transferring them to production environments
- Familiarity with aseptic drug manufacturing and methods like QbD
- Lyophilization e
xperience in developing, optimizing and transferring freeze-dried products, including thermal analysis (DSC, FDM, XPRD), thorough understanding of cycle design and development (including model-assisted approaches), and scale-up from lab to pilot/commercial scale - Understanding of
GMP and preparing technical documentation for regulatory submissions - Designing experiments (e.g., DoE) and analyzing data to
improve formulations and manufacturing processes - Strong teamwork skills for working with internal teams and external partners (e.g., CROs/CMOs)
- Ability to handle deviations, implement corrective actions, and improve manufacturing processes.
- Working knowledge of
oligonucleotide-based therapies:
(e.g., ADCs, proteins, RNA-based drugs) - Familiarity with process development for clinical-grade parenteral drug products
- Proven experience in related fields such as pharmaceuticals, biotechnological product development, and advanced drug delivery platforms
Qualifications:no
- Ph.D., Master's or Bachelor's Degree in Chemistry or related disciplines: With 2+ years (Ph.D.), 5+ years (Master's), or 8+ years (Bachelor's) biopharmaceutical experience
- Proven expertise in formulation and manufacturing process development for parenteral and aseptic products, including lyophilized dosage forms
- Demonstrated capability in
lyophilized cycle development and optimization
-
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