Sr CMC Manager Development

Sr CMC Manager Development

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About us

Associates in Scientific Management is a boutique recruiting organization, working within the bio-tech and pharmaceutical industry. Our company works in many facets of the industry: IT, Finance, Marketing, Analytics, Bio-statistics, Clinical Development, Quality and PV, Manufacturing, and Research and Development. We specialize in working with small to mid-sized pharmaceutical or bio-tech clients.

Sr Manager CMC Development

Summary of Position:

This position will manage and monitor project/s in Chemistry Manufacturing and Controls (CMC) area for activities such as formulation development, vendor selection, and CMC regulatory writing. This position reports to the Director, CMC

This position is expected to author regulatory submission such as IND, IMPD, annual report, meeting requests with the agency, and response to the questions by the Agency for the assigned projects.

The candidate for this position will also be supporting activities such as defining a scope of work, vendor selection, timeline and budget monitoring, invoice processing, project related shipments and communication with other departments regarding the assigned projects.

Duties and Responsibilities:

The responsible candidate will manage the developmental, clinical trial material and registration batches related activities for projects that mainly include oral solid and liquid dosage forms (active and placebo) intended to be utilized in phase I-III clinical trials (conducted in US and ROW).

• Vendor Selection and Project Start-up:

· Prepare request for proposals (RFP) for the projects

· Review CRO/CMO project proposal prior to selecting the vendor

· Prepare CRO/CMO vendor comparison and assist to select the appropriate CRO/CMO

· Assist Legal/Procurement and Quality Assurance (QA) department to complete confidentiality agreement (CDA), master service agreement (MSA) and quality agreement (QAG)

· Monitor vendor activities by arranging meetings on regular/as-needed basis

· Participate in vendor audits

• Formulation and Process Development:

· Review the scope of work and allocate available API inventory for different stages of project, manage shipment of API to the selected CMO. Make the reference standards and impurities available as needed

· Prepare a project timeline for drug product availability based on planned regulatory submission, clinical study initiation and feedback from CMO

· Review prior formulation development, excipient compatibility work, literature search to suggest candidate formulations and process for feasibility batch.

· Review and approve feasibility master manufacturing and packaging batch records, manufacturing protocols, review and/or provide analytical protocols, methods and reports to appropriate analytical SME

· Suggest suitable Design of Experiments (DoE) for formulation/process optimization, monitor execution of the DoE studies

· Review/author formulation development reportand facilitate change controls for the same

· Monitor manufacturing and packaging activity progress

· Review executed records and CoA/CoC for accuracy before batch release

· Provide stability protocol to analytical SME for review

· Manage the labeling of the CTM at manufacturing facility or another CRO as appropriate for the phase of clinical study

• Regulatory Authoring:

· Compile all the project specific supporting data in a shared folder

· Author regulatory submission such as IND, IMPD, annual report based on the data collected for the reporting period

· Manage and monitor data QC, QA review and approval of the regulatory document

· Provide response to the questions and an additional information as requested by the Agency

• Bachelor degree or equivalent with 10 years’ experience.

Pharm.D., Master’s degree or Ph.D. with 5 years of relevant experience.

• Pharmaceutical Sciences/technology related experience with emphasis on CMC.
• Regulatory and or project management experience after basic formulation experience is a plus.

Writing skills emphasizing on the content, structure and flow of the document, formatting

• and presentation for MS Word and PowerPoint documents is required.
• Writing skills emphasizing on the content, structure and flow of the document, formatting and presentation for MS Word and PowerPoint documents is required.
• Working knowledge of and experience with cGMP requirements, and applicable regulatory CMC documents.
• Understand protocols, writing SOPs, and technical knowledge of the manufacturing and testing drug product.

Please Contact:

Janice Walsh,ASM

Job Type: Full-time

Pay: $100,000.00 - $145,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Paramus, NJ: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Formulation: 2 years (Required)

Work Location: One location