Senior/Director, CMC and Technical Operations

Company: Veloxis Pharmaceuticals, Inc.
Location: Cary
Posted on: August 7, 2022

Job Description:

The (Senior) Director, CMC and Technical Operations position is responsible for all technical and CMC oversight to support the Company's product portfolio and pipeline from early stage development through post approval requirements. As the Company does not have its own manufacturing facility, this role is responsible for working directly with the Company's CDMO partners to ensure products are being manufactured in compliance with Regulatory and Company-desired requirements. This role requires a high level of external communication and interaction with the Company's CDMO and license partners as well as the ability to manage multiple projects through execution to meet the Company's objectives. The Director, Technical Operations will work on project teams with support from Supply Chain, Regulatory, Quality, and Clinical Development to drive the growth and the development of the Company's products.
SUMMARY OF KEY RESPONSIBILITIES

• Oversee the manufacturing of the Company's products for commercial distribution in the US and European markets and clinical trials;
• Oversee tech transfer or validation of any new manufacturing or packaging operations, as required, at CDMOs to secure the operation of the Company's products;
• Act as Man-In-Plant at CDMOs during projects requiring Company oversight, compliance, and support;
• Ensure that production at CDMOs is performed in accordance with cGMP, and that CMOs follow manufacturing and packaging processes, as instructed and approved by the Company;
• Efficiently communicate project tasks, deliverables and timelines to CMOs, ensuring that critical deadlines are agreed upon;
• Author CMC documentation in a timely manner to support regulatory filings, including but not limited to IND, pre- and post-approval changes;
• Work with Director, QC in review and trending of analytical activities, as well as supporting investigations for OOS/OOT occurrences including, but not limited to method development, method validation, manufacturing process controls and root cause investigations;
• Author, review and/or approve all technical related protocols, SOPs, MBRs, change controls, and reports, as needed; ensuring delivery of those reports to other Company departments (QA, RA), CDMOs, and/or license partners;
• Work with Quality to review product performance to assess needs for process improvements from a manufacturing and analytical perspective;
• Perform adequate due diligence from a technical/CMC perspective on new product opportunities presented by Company's Business Development team;
• Seek and recommend initiatives to streamline the manufacturing process and analytical release of the Company's product(s), including scale-up, process analytical technology, logistics strategies with drug product manufacturer;
• Oversee that the selection, qualification and manufacturing process transfer to drug product supplier are performed to meeting regulatory requirements, timeline, and budget;
• Prepare, justify and present budgets for Technical Operations, ensuring adequate spending and adherence to financial plan; ensure that contractor invoicing is accurate against quotes as approved by the Company;
• Seek and recommend cost-reduction initiatives by scouting new/potential vendors for activities and streamline processes, without compromising the Company's high quality standards;
• Support partners in all activities related to technical operations;
• Prepare SOPs in accordance with the needs of the Technical Operations department;
• Assist in the department's successful and efficient execution of departmental/area goals;
• Support the Quality Assurance department in auditing activities of Technical Operations' contractors;
• Prepare for regulatory agency inspections, including pre-approval inspections at the Company's facilities and key contractors' facilities;
• Stay abreast of scientific literature and regulatory guidelines pertinent to CMC, manufacture and the therapeutic area(s) of the Company's product(s).
  REQUIRED QUALIFICATIONS AND SKILLS
  • BS/MS/PhD in Chemical Engineering or closely related field with 10+ years of experience in CMC and pharmaceutical manufacturing environments.
  • Extensive knowledge of manufacturing processes for drug substance and drug product; more specifically, biologics is preferred.
  • Extensive knowledge and understanding of all stages of pharmaceutical development and scale-up / manufacturing principles across typical drug product operations.
  • Extensive knowledge of all CMC requirements and strategy for regulatory submissions.
  • Proficiency in quality procedures and GMPs.
  • Demonstrated consistency in applying and furthering scientific / technical concepts and techniques to efficiently and effectively resolve scientific / technical issues.
  • Efficient time management, capable of multi-tasking and prioritization; structured and proactive work style.
  • Excellent interpersonal and communication skills; effective presentation skills to both internal and external audiences.
  • Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.
    Travel Requirements: 30%

Keywords: Veloxis Pharmaceuticals, Inc., Cary , Senior/Director, CMC and Technical Operations, IT / Software / Systems , Cary, North Carolina