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Montreal, Canada Milestone Pharmaceuticals, Inc. Full timeAssociate Director/Director, Chemistry Manufacturing and Control Join to apply for the Associate Director/Director, Chemistry Manufacturing and Control role at Milestone Pharmaceuticals, Inc. Position title: Associate Director/Director, Chemistry Manufacturing and Controls Reports to: VP, Chemistry Manufacturing and Controls Manages: GMP pharmaceuticals...
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Montreal, Canada Milestonepharma Full timePosition title: Associate Director/director, Chemistry manufacturing and controls Reports to: Vp, Chemistry Manufacturing and Controls Manages: GMP pharmaceuticals Production Location: montreal, QC or Charlotte, NC (possibility of remote position) duty and responsibilities - Management of the GMP Production of drug substance and drug products at...
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Montreal, Canada Milestone Pharmaceuticals, Inc. Full timeA leading pharmaceuticals company is seeking an Associate Director/Director for Chemistry Manufacturing and Control. This individual will manage GMP production and ensure compliance with regulatory requirements while providing project management oversight. The ideal candidate has at least ten years of pharmaceutical industry experience, including direct GMP...
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Associate Director/Director, Chemistry Manufacturing and Control
4 weeks ago
Position title: Associate Director/director, Chemistry manufacturing and controlsReports to: Vp, Chemistry Manufacturing and ControlsManages: GMP pharmaceuticals ProductionLocation: montreal, QC or Charlotte, NC (possibility of remote position)duty and responsibilitiesManagement of the GMP Production of drug substance and drug products at contract manufacturing organizations (CMOs) intended for nasal and sublingual administrationCompliance against applicable cGMPs, regulatory requirements and company’s SOPs and policiesCollaborate with internal teams, consultants, CMOs and suppliers, providing project management oversight for CMC, and in accordance with development plansExecute external development and manufacturing activities at CMOs, ensuring collaboration, communication, scientific expertise, and attention to detailCreation of a positive work environment by sharing and demonstrating functional/technical knowledgeReview essential elements of scale-up and technology transferManage the technical oversight and timeline of outsourced activitiesApply technical expertise to support the development of new formulations, and manufacturing processes for nasal, sublingual, and transdermal dosage formsReview batch production records and development protocols to ensure cGMP complianceReview deviations, investigations and CAPAs and make recommendations to Quality AssuranceReview and approve technical drug substance and drug product documents for regulatory submissions, ensuring all documentation is approved and processed within budget and timelineEducation, background, knowledge and skillsMS or PhD in Pharmaceutics, Pharmaceutical Chemistry, Medical Chemistry or Chemical EngineeringApproximately Ten years of experience in the pharmaceutical industry or CMO’s including virtual pharmaceutical development with direct GMP manufacturing experienceExperience working with drug substance, and drug product contract manufacturers in the US, EU and AsiaExperience with intranasal and sublingual drug delivery systems for formulation and manufacturing is required, as is experience with drug/device combinations.Knowledge of formulation development, analytical development, technology transfer, cGMP, FDA, EU, and ICH regulation/guidelines, as well as requirements for CMC content of regulatory submissions;Experience with project management tools including Excel, PowerPoint, Project Team and Acrobat.key attributesSuperior interpersonal abilities—including working in a multi-cultural, multi-lingual environment.Exceptional communication skills, with both written and oral presentation abilities.Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining positive working relationships.Able to travel approximately 15% of the time, including international travel when appropriate.Milestone Pharmaceuticals is an equal opportunity employerDisclaimer: The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, but rather are intended only to describe the general nature of the position.COVID-19 VACCINATION POLICY: All Milestone employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.EEOC STATEMENT: Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law. #J-18808-Ljbffr
