CMC Operations Manager

Location
94404, Foster City
Posted
Nov 19, 2020
Ref
CMCOM11192020
Discipline
Science/R&D, CMC
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

The CMC Operations Manager will have an emphasis on chemistry and be a key player on our CMC team (small molecules). The CMC Operations Manager will support our global pre-clinical and clinical development and commercial programs.  Reporting directly to the Sr. Director, CMC (small molecules), this role will oversee and support strategy, plans and objectives for all chemistry, manufacturing, and controls (CMC) activities.

Responsibilities:

  • Plan and support stage-appropriate development for drug substance, drug product, and analytical development.
  • Collaborate with internal and external (CMOs) in developing/authoring protocols and reports.
  • Work closely with external CMO/CRO and characterize small molecule-based compounds to support analytical development/validation activities.
  • Review and/or author method development/validation protocols, development reports, data analysis including trend analysis, deviations, out-of-trend and out-of-specification investigations and efficient closure of the investigations, etc. 
  • Author CMC sections for global regulatory submissions.
  • Assist in maintaining CMC documentation systems and responsible for writing development reports as appropriate. 
  • Implement stage-appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant quality and regulatory standards.
  • Assist in selection and management of contract research and contract manufacturing organizations (CMOs & CROs) for DS and DP optimization, technology transfer, cGMP manufacture and supply of Drug Substance (API), and Drug Product (DP).
  • Assist in setting up contracts and agreements, CDAs, MSAs, etc. for all Pharmaceutical Development materials and services. 
  • Develop and implement strategy and DOE (design of experimentation), and apply quality by design (QBD) principles from early-stage of development, and continue during scale-up/tech transfer to a commercial site for controlling the quality of bulk API and DP using CROs and CMOs.

Qualifications:

  • Bachelor's degree with a minimum of 5 years or Master’s degree with 2-3 years of relevant experience in the pharmaceutical industry with chemistry, analytical method development, and technical operation in small molecule drug substance and drug product is required. 
  • Experience in oral solid-dosage like capsules and tablets is desired.
  • Experience with standard small molecule analytical techniques such as HPLC, Karl Fischer, IR, etc, and interpreting MS, IR, NMR, DSC, light scattering, and microscopic data is preferred.
  • Ability to summarize data sets and draw appropriate conclusions also desired.
  • Track record with experience in analytical method development, scale-up/manufacturing of cGMP materials for global drug product supply, and technical operation/technology transfer.
  • Understanding of drug substance, drug product and analytical methods development, manufacturing operation, and clinical supplies management is required.
  • Strong oral and written communications skills.
  • Work in a fast-paced environment with multiple priorities.
  • Adaptability, flexibility, and resourcefulness to roll-up-sleeves and multi-task to thrive in a small company environment.
  • Travel to CMOs/CROs as needed to support project needs.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two-novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.