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