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Company

Original Job Post

Amgen · 1 week ago

Director Process Development - Pivotal Biologics

Thousand Oaks, CA

Full-time

Hybrid

Director

10+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Actively Hiring

Comp. & Benefits

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Responsibilities

Lead a high-performing technical team, fostering diversity in scientific and engineering skills.

Interface seamlessly with partners in Process Development, Quality, Regulatory, and Manufacturing to optimize drug product development.

Provide visionary leadership in devising strategies and experimental plans for drug delivery, emphasizing biological efficacy, ease of administration, and enabling target product presentations. Offer oversight and direction to teams handling formulations and processes across multiple programs and therapeutic areas.

Efficiently organize and leverage resources for maximum output while fostering innovation.

Develop and communicate a compelling department vision, aligning each team member's work with the broader organizational goals.

Provide input on program strategy, budgets, timelines, and project plans. Ensure the management and fulfillment of technical and business requirements.

Navigate ambiguity and rapid changes adeptly, smoothly transitioning and rallying the team when needed.

Guide and mentor team members in day-to-day performance, long-term career development, and during times of change.

Possess expertise in process engineering, pharmaceutical sciences, formulation development, and drug delivery technologies.

Regularly engage with senior management and executives, shaping comprehensive departmental direction.

Contribute to regulatory filings, including INDs, CTAs, and MAs; assist in addressing regulatory authorities' inquiries as needed.

Rigorously review all scientific and regulatory deliverables.

Demonstrate flexibility for domestic and international travel, up to 10% of the time.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Process DevelopmentManagerial ExperienceLeadershipTeamworkProblem-SolvingFormulationDrug stability assessmentManagement experienceScientific discipline knowledgeRegulatory requirements knowledgeRegulatory submissions preparationInteracting with regulatory agenciesProblem solvingPeople-centered leadershipMentoringCoachingMotivatingNetworkingCommunicationPresentation

Required

Doctorate degree and 4 years of Process Development experience

Master’s degree and 8 years of Process Development experience

Bachelor’s degree and 10 years of Process Development experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred

Doctorate degree in one of the following areas: Biology, Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline.

10+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization.

10+ years of management experience.

Demonstrated knowledge of drug stability assessment and mitigation strategies.

Demonstrates people-centered leadership in all of interactions: excels at problem solving, asks tough questions, makes difficult decisions, and can strongly defend a position but also be responsive to feedback.

Strong focus on mentoring, coaching, motivating, and providing career and scientific/technical advice to staff.

Strong networking skills to work across organizations to advance innovative processes, approaches, and methodologies.

Executes with a sense of purpose; drives course corrections where appropriate.

Excellent written, verbal, communication, and presentation skills. Demonstrates the ability to distill, craft, and present key messages relative to diverse audience requirements, accurately identifying the correct strategic altitude and communication style.

Established knowledge of applicable global regulatory requirements and experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Group medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements

Company

Amgen

Glassdoor

4.2

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

Founded in 1980

Thousand Oaks, California, USA

10,001+ employees

http://www.amgen.com

H1B Sponsorship

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