Develop and characterize drug product formulations and manufacturing processes for biologic therapeutics from preclinical development through clinical proof of concept.
Responsibilities
Own & support stability / in-use / process studies
Perform analytical assays & support troubleshooting
Analyze & communicate results
Write technical reports and communicate technical updates
Collaborate closely with highly matrixed team members
Requirements
Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent
Perform laboratory analysis and sampling of raw materials, intermediates, finished products, cleaning verification samples, stability samples and other miscellaneous samples following relevant SOP’s while adhering to current Good Manufacturing Practices (cGMP) to ensure they meet the required quality standards and specifications.
Compensation
The salary range for this role is $60,000–$70,000.
Responsibilities
Perform laboratory analysis and sampling of raw materials, intermediates, finished products, cleaning verification samples, stability samples and other miscellaneous samples following relevant SOP’s while adhering to current Good Manufacturing Practices (cGMP) to ensure they meet the required quality standards and specifications.
Perform basic maintenance of technical equipment, use of basic troubleshooting techniques and laboratory stock management
Deliver experimental output with a high degree of scientific integrity, both on time and on target, with a focus on quality.
Actively demonstrate strict compliance with current Good Manufacturing Practices and Good Documentation Practices (cGMP and GDP), Environment, Health and Safety (EH&S) and other relevant standards in all aspects of work.
Manages data by following established procedures, standards and processes. Uses the concepts of ALCOA+ to maintain Data Integrity.
Requirements
BS in Chemistry
Skills
QC Specialist: Analytical Method Validation and Transfer
Lead validation, qualification, verification, and transfer of analytical methods for biologic drug substance and product testing.
Compensation
The salary range estimated for this position based in California is $91,000.00–$101,001.00.
Responsibilities
Lead the validation, qualification, verification, and lifecycle management of analytical methods supporting biologic drug substance and drug product testing.
Serve as the technical lead for analytical method transfers to internal laboratories, contract testing laboratories (CTLs), and regulatory affiliates.
Author and review method transfer plans, protocols, gap assessments, risk assessments, statistical evaluations, and final transfer reports.
Provide technical expertise, training, troubleshooting, and hands‑on support during method validation and transfer activities.
Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, and external partners to support product development, commercialization, and post‑approval lifecycle activities.
Requirements
Bachelor's degree or equivalent in Biochemistry, Biology, Biotechnology, Microbiology, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
Nice to have: cGMP
Nice to have: ICH
Nice to have: USP
Nice to have: EP
Skills
Analyst, Development Services - Analytical Development
Analyst in Process Analytics responsible for analytical testing of antibodies and recombinant proteins, method troubleshooting, documentation, and regulatory compliance.
Responsibilities
Execution of analytical testing on antibodies and other therapeutic recombinant proteins
Demonstrate good knowledge across a variety of test methods including capillary electrophoresis, HPLC/UPLC, oligosaccharides profiling, qPCR and ELISAs
Perform method troubleshooting and optimization
Exercise technical discretion in the execution and interpretation of experiments
This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent will support the reference standard development program within the Global Biologics department, participating in the development of replacement and new reference standards/ARMs.
Responsibilities
Works with key stakeholders to develop reference standards for biotechnology pharmaceutical products including proteins, peptides, heparins, antibiotics, and advanced therapies.
Oversee and facilitates the development of reference standards and solutions to address analytical challenges associated with biological medicines.
Supports day-to-day operations of the Stability program covering the USP Biologics RS catalog inventory.
Reviews testing history and drafts test protocols for lab submission based on designated testing requirements and schedules.
Assists laboratories to ensure testing is completed accurately and in timely manner.
Requirements
Ph.D. degree in Biochemistry, Analytical Chemistry or Biological Sciences
Analytical Development Lead responsible for characterizing ingredients (bioactive proteins, HMOs, functional lipids) and building analytical methods to measure them from R&D to pilot and regulatory batches.
Compensation
Competitive salary, ESOP, part health insurance coverage, part transportation and lunch coverage.
Responsibilities
Define and deliver Nūmi's analytical strategy across the ingredient portfolio.
Build the full characterisation package of each ingredient: identity, purity, composition, isoforms, and post-translational modifications.
Benchmark ingredients against human milk counterparts and marketed references.
Characterise the process-related impurities (host cell proteins, residual DNA, media components).
The QC Analyst role involves the analysis of raw materials, in process and finished products, reviewing analytical data, and performing instrument qualification.
Responsibilities
The analysis of raw materials, in process and finished products
Reviewing analytical data, analytical reports and performing peer reviews
Performing analytical method transfers and compendia verifications
Instrument qualification, maintenance and troubleshooting
QC Analyst responsible for analysis of raw materials, in-process and finished products, reviewing analytical data, performing method transfers and verifications, instrument qualification, protocol generation, and training team members while ensuring compliance with GMP and safety regulations.
Responsibilities
Analyze raw materials, in-process and finished products
Review analytical data and reports
Perform analytical method transfers and compendia verifications
Qualify, maintain and troubleshoot instruments
Generate protocols for method verification/transfer
QC Analyst INewVeranova L P · West Deptford, US
Senior Scientist I, Documentary StandardsUSP Brand · India