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Vice President, Technical Operations

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

Job Description:

Company: Stratacuity: Proven Scientific Placement

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Head of Technical Operations (Vice President/Senior VicePresident)1071305

Job Scope and Purpose:

Our Cambridge-based client, an emerging company in the precisiononcology space, has engaged Stratacuity on a leadership opportunityto head and build out a robust Technical Operations department.This experienced professional will build out our client'smanufacturing and supply chain strategy, including early stage andCMC development, for all pipeline programs in preparations forcommercialization. The ideal hire will have ample experience insmall molecule drug development, including the build out ofmanufacturing resources and capabilities, securing relationshipswith key suppliers and external manufacturing partners, preparingfor and support regulatory interactions and filings, and preparingfor commercial activities. Most importantly, this critical hiremust understand and be excited about a small company environmentand constructing a high performing team and network, while stillwilling to be hands on in the early stages of the group buildout.Intrigued? Reach out to Kevin Rees or Todd Jamison to learnmore!

Primary Job Responsibilities:

Plan and implement a robust product manufacturing strategy toensure timely and adequate supply of drug product for developmentand clinical programs, and prepare for commercialization based onaccelerated approval pathways

Develop a long-range plan for manufacturing and supply chainoperations

Coordinate with Regulatory leadership on the implementation ofan overall CMC strategy for clinical to commercial stage products,including strategic sourcing, tech transfer, process validation,and clinical and commercial supply manufacturing

Present manufacturing plans and updates to Executive and BODleadership, and business partners as needed

Negotiate, select and manage vendors to ensure quality clinicaland commercial product, and perform on-site visits to these keysuppliers (domestic and international)

Ensure all manufacturing and process validation activities arecompleted in accordance with regulatory and quality expectations inorder to support relevant regulatory submissions globally

Strategize, develop, and maintain robust clinical and commercialsupply chain, enact risk mitigation procedures, and identify futuretrends

Prepare documentation, regulatory reports and otherdocumentation for CMC sections of regulatory filings

Coordinate and direct process development activities, andmanufacturing improvement processes

Provide CMC expertise in the evaluation of potentialin-licensing opportunities

Directly supervises both existing and future team members, andprovides supervisory responsibilities to ensure proper hiring,training and mentorship for employees in the department

Primary Job Requirements:

Minimum of a BS in an applicable field of study, with anadvanced degree strongly preferred, and at least 15 years ofexperience in manufacturing and CMC activities in thepharmaceutical industry

Previous experience with oncology drug development preferred

Demonstrated leadership experience with supply chain,manufacturing development strategy and oversight required,including the establishment of improvement and deliveryobjectives

Proven ability to initiative, develop and manage supplierrelationships for clinical and commercial manufacturing

Experience in overseeing manufacturing, labeling and packaginginitiatives in global markets to support product launch andcommercialization is a requirement

In-depth expertise in small molecule CMC activities, fromIND-enabling to commercial-scale requirements

Outstanding communication skills (verbal, written andpresentation) with internal and external colleagues

Proven decision-making and problem-solving skills, and awillingness to join a rapidly growing organization

Must be willing to accommodate travel to manufacturing partnersas needed (estimated 20-30% travel)

About Stratacuity:

Whether you are seeking a career change or simply interested inbecoming part of our network, you will appreciate the ethicsguiding each Stratacuity team member. We build lastingrelationships with exceptional biopharmaceutical talent and takegreat care to protect your personal information. Upon receivingyour inquiry, you may be directly contacted by a Stratacuity teammember to discuss your career goals. We will not share yourinformation with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/AffirmativeAction Employer. All qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, age, sexual orientation, gender identity, nationalorigin, disability, protected veteran status, or any othercharacteristic protected by law. Stratacuity will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact us.

Code:TechOps

EEO Employer

Apex Systems is an equal opportunity employer. We do notdiscriminate or allow discrimination on the basis of race, color,religion, creed, sex (including pregnancy, childbirth,breastfeeding, or related medical conditions), age, sexualorientation, gender identity, national origin, ancestry,citizenship, genetic information, registered domestic partnerstatus, marital status, disability, status as a crime victim,protected veteran status, political affiliation, union membership,or any other characteristic protected by law. Apex will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact our EmployeeServices Department at employeeservices@apexsystemsinc.com or844-463-6178.

Apex Systems dba Stratacuity, is an equal opportunity employer.We do not discriminate or allow discrimination on the basis ofrace, color, religion, creed, sex (including pregnancy, childbirth,breastfeeding, or related medical conditions), age, sexualorientation, gender identity, national origin, ancestry,citizenship, genetic information, registered domestic partnerstatus, marital status, disability, status as a crime victim,protected veteran status, political affiliation, union membership,or any other characteristic protected by law. Stratacuity willconsider qualified applicants with criminal histories in a mannerconsistent with the requirements of applicable law.

Keywords: Stratacuity: Proven Scientific Placement, Waltham , Vice President, Technical Operations, Other , Cambridge, Massachusetts

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