Assoc Mgr, Aseptic Manufacturing

Gilead Sciences, Inc. La Verne , CA 91750

Posted 4 months ago

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Essential Functions:

  • Plans, executes and tracks a variety of manufacturing projects both internally and in coordination with contract manufacturers.

  • Contributes to the development of department strategies.

  • Exercises judgment within generally well-defined procedures and practices to determine appropriate action.

  • Normally receives no instruction on routine work, and general instructions on new assignments.

  • Oversees and contributes to the completion of all technical and operational activities for manufacturingthrough management of internal and external resources.

  • Manages complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory requirements.

  • Generatesand maintains

Learning Plans and Training Modules. Trains new employees in SOPs and documentation systems.

  • Responsible for initiating and directing the implementation of manufacturing changes on multiple projects across multiple production sites.

  • Evaluates the tracking flow of projects against established timelines, and prioritizes activities based on changing requirements.

  • Directs the timing and problem resolution while coordinating the approvals between Regulatory, Quality Assurance, Marketing, Legal, Manufacturing and Package Engineering.

  • Ensures all manufacturing documentation (Specifications, Master Production Records, and Worksheets etc.) is completed in a timely and accurate manner.

  • Directs activities within the manufacturinggroup to meet company goals including production schedules, budgeting, training, and performance reviews.

Physical Requirements for the role:

  • Must be able to work on a rotational shift schedule alternating between day shift and grave shift

  • Must be able to work weekends

  • Must be able to work holidays

  • Must be able to operate and qualify for respirator usage

  • Must be able to see and distinguish all colors and shades

  • Must be able to stand for a continuous 4 hours

  • Must be able to change into Gilead gowns and work attire as required for the task

  • Occasionally lift 50 lbs

  • Routinely lift 25 lbs

Knowledge, Experience, and

Skills:
  • 7+ years of relevant experience and a BS or BA.

  • 5+ years of relevant experience and a MS.

  • Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.

  • Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC).

  • Is able to provide solutions to moderately complex to semi-routine problems

  • Demonstrates excellent verbal, written, and interpersonal communication skills

  • Demonstratesstrong computer, organizational, and project management skills.

  • Demonstrates ability to recognize deviation from accepted practice.

  • Demonstrates ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.

  • Demonstrates strong project management skills.

  • Demonstrates an ability to communicate effectively with peers in organization.

  • Demonstrates ability to successfully supervise and support junior staff.

#LI-JS1

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

Conformment la Loi " Informatique et Liberts " (06/01/78), nous vous informons du fait que les donnes personnelles renseignes pourront faire l'objet d'un traitement informatique par Gilead et pourront tre transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accs, de rectification et de suppression des donnes vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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Assoc Mgr, Aseptic Manufacturing

Gilead Sciences, Inc.