Technical Operations Manager (#3699)

The Company

The company is committed to excellence, and continuously strives to provide a unique, challenging and rewarding work environment designed to motivate and recognize the contributions of all employees.

The Position

Our client has an immediate opening for a Technical Operations Manager, in the Manufacturing Operations Group. The successful candidate will be responsible for participating in and overseeing some of the various manufacturing, development, formulation, process, technical, validation, quality control, and compliance activities with existing and potential CMO's and CRO's for both drug products and drug substances.

Essential Duties:

• Participate in and help oversee all manufacturing, filling, labeling, packaging and quality operations of all the company's requirements at third party organizations for both drug substance and drug product (clinical trials, toxicology, commercial supplies, etc.)
• Participate in quality audits of all potential 3rd party organizations.
• Write, review and approve all SOP's as they relate to manufacturing/technical operations
• Evaluation of all new molecules as it pertains to health, safety and environmental regulations.
• Responsible for review, monitoring and approval of all company and 3rd party validation work including computer validations, document systems, IQ/OQ/PV, cleaning validation, method validation, test method transfer, calibration, preventative maintenance, stability program, compliance and environmental programs.
• Maintain a technical data base and keep on file all Master Documentation with history for all drug substances and drug products, Also keep on file all approved Manufacturing documentation, Quality agreements, supplier audit reports, site visits etc.
• Collaborate with and support the product development and research groups in all activities related to process development and formulation.
• Manage all aspects of the stability program as well as reference standard program.
• Assist in process development, formulation development, validations and method transfers
• Review ( prepare if required) and approve all specifications, master batch records, validation protocols, stability protocols, method transfers, certificates of analysis, pertinent SOP's and all related documentation.
• Participate in project development team meetings and communicate technical issues and timelines to the group.
• Assist with compilation of CMC and DMF data submissions.
• Establish goals and objectives for the technical department in conjunction with the other departments and overall company strategy.

The Candidate

The successful candidate should possess the following qualifications, experience and personal competencies:

• Qualified candidates will have a minimum of a Bachelor of Science degree with 5 to 10 years previous relevant industry experience in manufacturing both clinical and commercial stage products in a pharmaceutical company
• Successful candidates will have demonstrated knowledge of GMP manufacturing and ICH guidelines for pharmaceutical drug products
• Experience with manufacturing a variety of drug products, including parenterals and/or oral capsules, is required
• Knowledge of commercial validations is an asset
• Strong planning, organization, and problem solving skills are essential
• Solid communication skills (verbal and written) are required
• Strong interpersonal skills an asset

The successful candidate must be willing and able to travel frequently (travel estimated at up to 50% time) within Canada, the United States and Europe

Reporting To

Executive Director, Manufacturing Operations

Location

Markham, ON

Remuneration & Benefits

Competitive compensation package, including dental and medical.

Apply

If you are interested, and feel you are qualified, please send your resume, in confidence, to Elesha Browne at: ebrowne@cambridgemgmt.com