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Director, Sterile Drug Products - Manufacturing

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Director, Sterile Drug Products - Manufacturing Company: NATIONAL POSTDOCTORAL ASSN

Location: Cambridge

Posted on: September 12, 2020

Job Description:

National Postdoctoral Association Career Center Director,Sterile Drug Products - Manufacturing

MT Director, Sterile Drug Products - Manufacturing In this role,you will have an opportunity to lead the overall strategy formanufacture of drug products to advance Mersana’s ADC programs fromclinical through commercial launch. You will form closepartnerships with CMC functional leads, supply chain and CMO’s toestablish regulatory, clinical, quality and CMC plans to ensure aunified approach for drug product manufacture. This role will havea huge impact as you create and develop registration and validationstrategies. You will have the opportunity to learn and deepen yourexperience as we grow. To be successful, you will have beeninvolved in the end to end manufacture of clinical and commercialsupply based on CMC and clinical development plans. You’ll alsohave substantial experience managing CROs, CMOs and otherexternal resources, and experienced in technologies related toparenteral drug product manufacture such as aseptic processing andlyophilization. This position reports to the Executive Director,Sterile Drug Products.

How do you know if you’re the right fit?

If you are a highly self-motivated, driven individual who enjoysthe challenges and opportunities available in a growing andtransforming organization, this will be an opportunity for you toapply yourself, learn and deliver. You’ll thrive in an environmentwhere you are involved in both the strategy (the bigger picture)and in the execution, and value proactive collaboration andteamwork to be successful. You will serve as the DP process andmanufacture technical expert on CMC program teams and beresponsible for delivery of manufacture and validation objectives,budgets, and timelines in alignment with registration andcommercial strategies.

Provide manufacturing leadership in support of Mersana’sAntibody Drug Conjugate (ADC) development programs.

Collaborate and coordinates in cross-functional teams, bothinternally and at CRO/CMOs, to develop robust, and scalableprocesses.

Lead drug product manufacturing and validation activities forparenteral dosage forms for biologics and processes across a globalsupplier network.

Resolve complex commercial manufacturing issues being mindful ofSupply, Quality, and Regulatory through effective management ofdeviations and change control development and implementation, CAPAmanagement and risk assessments.

Ensure ongoing production of timely, quality drug product byleading tech transfer, commercial manufacturing, technical support,and process monitoring/trending activities

Be the person in-plant during tech transfer, validationactivities and routine production as necessary.

Establish and maintain an understanding of current trends,emerging process technologies and ensure full awareness of currentand emerging global capabilities for ADC/Biologics production.

Execute Quality by Design (QbD) principles to define the designspace and develop overall control strategy.

Construct and manage controlled experiments to optimize andscale lyophilization processes.

Develop technical summaries and contribute to regulatoryfilings.

Presents results and progress of CMC programs to internal andexternal audiences as appropriate.

Create, review and approve technical documents including batchrecords, engineering / development reports, and risk / validationassessments, Validation Master Plans and PPQ reports.

Requirements

The other stuff

This role is typically a role best suited for a MS/PhD inPharmaceutical Sciences/Engineering who possess at least 10 years’experience in the pharmaceutical/biotechnology industry.Additionally, you’ll have at least 7 years’ direct experience in DPmanufacture of sterile drug products including lyophilizationdevelopment and validation. It will also be important for you topossess stellar communication, organizational and negotiatingskills as you will be working with a variety of internal andexternal partners. Experience with biologics preferred.

Position is eligible for bonus, option awards and benefitsincluding medical, dental and life insurance, 401(k) participation,vacation and paid holidays.

Successful candidate must be authorized to work in the UnitedStates.

Mersana Therapeutics, Inc. is an equal opportunity employer.

Job Information

Job ID: 54280452

Location:

Cambridge, Massachusetts, United States

Position Title: Director, Sterile Drug Products -Manufacturing

Company Name: Mersana Therapeutics

Job Function: Biotherapeutics

Job Type: Full-Time

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Keywords: NATIONAL POSTDOCTORAL ASSN, Cambridge , Director, Sterile Drug Products - Manufacturing, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director, Sterile Drug Products - Manufacturing, Other , Cambridge, Massachusetts

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