20 days old

Manager Drug Product

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    118925282
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As part of this shift, we have migrated all interviews to virtual interviewing via phone and video.

Position Summary:

Responsible for coordination of commercial Drug Product Contract Manufacturing organizations (CMOs), and other third party suppliers for products as identified. Responsible for tracking of ongoing manufacturing schedules to ensure commercial supply levels are maintained and inventory targets are met.

Primary Responsibilities:

  • Develops and maintains good working relationships with contract manufacturers.
  • Develop and maintain Drug Product manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.
  • Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
  • Maintains and follow through a consolidated ACADIA Manufacturing action log to ensure all manufacturing related actions are completed on time.
  • Prepare Annual Product Reports with Manufacturing CMOs according to ACADIAs needs.
  • Work with CMOs and ACADIA participants to schedule and coordinate Steering Committee Meetings.
  • Works with Quality Group and ACADIA Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
  • With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
  • Provide onsite process coverage as person-in-plant as needed
  • Develops, collects appropriate internal and external metrics to measure CMO and ACADIA performance.
  • Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
  • Supervise, train and mentor personnel as needed.

Education/Experience/Skills:

BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. A minimum of 5 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.

Must possess:

  • Contract service provider experience.
  • Strong understanding is required of the biopharmaceutical drug substance process including regulatory filings and quality inspections and audits.
  • Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
  • Extensive knowledge of current Good Manufacturing Practices (cGMPs)
  • Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
  • Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
  • Domestic and International travel is required for this role.

Scope:

Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of, managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.


PI118925282

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p style="text-align: center;"><strong>For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As part of this shift, we have migrated all interviews to virtual interviewing via phone and video.</strong></p> <p><strong><u>Position Summary:</u></strong></p> <p>Responsible for coordination of commercial Drug Product Contract Manufacturing organizations (CMOs), and other third party suppliers for products as identified. Responsible for tracking of ongoing manufacturing schedules to ensure commercial supply levels are maintained and inventory targets are met. </p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Develops and maintains good working relationships with contract manufacturers.</li> <li>Develop and maintain Drug Product manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.</li> <li>Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.</li> <li>Maintains and follow through a consolidated ACADIA Manufacturing action log to ensure all manufacturing related actions are completed on time.</li> <li>Prepare Annual Product Reports with Manufacturing CMOs according to ACADIAs needs.</li> <li>Work with CMOs and ACADIA participants to schedule and coordinate Steering Committee Meetings.</li> <li>Works with Quality Group and ACADIA Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.</li> <li>With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.</li> <li>Provide onsite process coverage as person-in-plant as needed</li> <li>Develops, collects appropriate internal and external metrics to measure CMO and ACADIA performance.</li> <li>Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.</li> <li>Supervise, train and mentor personnel as needed.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. A minimum of 5 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.</p> <p>Must possess:</p> <ul> <li>Contract service provider experience.</li> <li>Strong understanding is required of the biopharmaceutical drug substance process including regulatory filings and quality inspections and audits.</li> <li>Demonstrated experience with preparing/reviewing annual product review/product quality review reports.</li> <li>Extensive knowledge of current Good Manufacturing Practices (cGMPs)</li> <li>Able to operate effectively and with a strong sense of urgency in a fast-paced environment.</li> <li>Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.</li> <li>Domestic and International travel is required for this role.</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of, managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.</p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/G7wdpliaLVxEfpLZiqQEV"> <p>PI118925282</p>

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Posted: 2020-03-11 Expires: 2020-04-11

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Manager Drug Product

ACADIA Pharmaceuticals
San Diego, CA 92101

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