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
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