Director, Process Development jobs in United States
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Alkermes · 1 day ago

Director, Process Development

positionGreater Boston
timeFull-time
remoteOnsite
seniorityDirector/Executive
money$216K/yr - $244K/yr
date15+ years exp

Alkermes is a fully-integrated, global biopharmaceutical company committed to developing medicines for complex psychiatric and neurological disorders. The Director of Process Development will lead the Process Development Team in ensuring robust processes for the manufacture of high-quality therapeutics, while collaborating across various teams to drive decision-making and support drug development efforts.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead process development strategy for Alkermes products and ensure processes are suitable for the phase of development and ultimately for commercial manufacturing. This includes process design and development, scale-up and optimization, characterization and control strategy development and technical transfer to internal manufacturing site or CMO/CDMOs
Recruit, manage, train, motivate, develop, and mentor Process Development staff
Collaborate closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and/or external capabilities to assist in process development effort
Ensure process development approaches are suitable for progressive stages of small molecule pharmaceutical development as outlined in ICH and FDA guidance
Operation of the Process Development laboratories and GMP clinical manufacturing suites which are currently under development in Waltham, MA
Provide subject matter expertise in process development methodologies at Alkermes requiring internal execution and technical oversight/supervision
Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions
Guide and drive process development, design of experiments, product characterization and control strategy development
Develop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions
Ensure the team stays up to date with current technologies and manufacturing trends focusing on continuous improvement and operational excellence
Managing the team budget and supporting the planning of capital requirements for the future
Support the Regulatory group in responding to agency questions
Support process validation and commercial launch
Provide technical support to internal manufacturing sites and CMOs

Qualification

Pharmaceutical developmentProcess developmentGMP manufacturingTechnical transferDesign of experimentsData analysisRegulatory submissionsLeadershipCollaborationCommunication skillsStrategic thinking

Required

PhD or MS in Science or Engineering
15+ years technical and leadership experience in pharmaceutical development. This should include experience in Process Development, scaleup and GMP manufacturing with an established history of successfully developing and commercializing products and processes
Expertise and demonstrated experience in small molecule process development, scale up, control strategy development and technical transfer
Expertise in design of experiments, data analysis and data interpretation for process development studies
Experience managing contract drug development activities
Technical problem-solving ability utilizing current research and technologies
Broad understanding of the drug development process and the role and impact of process development within this process
Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
Strategic thinking and planning ability
Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills
Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities

Benefits

Annual performance pay bonus
Competitive benefits package

Company

Alkermes

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Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
dateFounded in 1987
location
Dublin, Dublin, IRL
people-size1001-5000 employees
web-link
http://www.alkermes.com

H1B Sponsorship

Alkermes has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)

Funding

Current Stage
Public Company
Total Funding
$250M
Key Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO

Leadership Team

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Craig Hopkinson
EVP, Research and Development, CMO
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Recent News

GlobeNewswire
Avadel Pharmaceuticals Announces that Avadel Shareholders Approve the Proposed Acquisition by Alkermes
2026-01-13
thefly.com
Avadel Pharmaceuticals shareholders approve acquisition by Alkermes
2026-01-13
TradingView
REG - Irish Takeover Panel - Disclosure Table
2026-01-09
Company data provided by crunchbase