Production Project Manager

Bachem AG•Vista, CA

4d•$103,511 - $142,327

About The Position

The Production Project Manager represents Production as a subject matter expert on cross-functional customer project teams. The role ensures timely completion of project-related tasks within the operating line and manages sub-teams as needed. The Production Project Manager proactively informs project leadership and business development or sales about scope changes, collaborates with customer SMEs and other cross-functional project managers to develop solutions for product-related issues, and shares responsibility for project success and key activities outlined in the PM guide. The position coordinates production, analysis, review, scheduling, process mapping, and improvement activities to keep projects on track. It also maintains product and batch records, prepares campaign reports, supports capital investment proposals, and participates in customer meetings and visits. The role acts as a link between customers and production, conveying customer needs, advocating for products, securing program resources, and promoting effective information flow and customer relationships.

Requirements

Bachelor's degree in Science or Engineering, such as Chemistry, Chemical Engineering, Biochemistry, or Biology, or a similar field.
4–6 years of experience in the Biotech, Pharma, or CMO industry, with good knowledge of CMC development of APIs and KSAs.
4–6 years of project management experience, including coordinating complex activities across multiple programs simultaneously and supporting customer interactions.
Good presentation and root-cause analysis skills to support investigations, ability to trend statistical data, and good understanding of chemistry and photosynthesis.
Knowledge of Chemistry, Manufacturing, and Controls (CMC) associated with IND and NDA filings.
Effective interpersonal and facilitation skills and ability to work well in a team environment.
Strong organizational skills, attention to detail, and ability to work in a fast-paced environment.
Ability to communicate proactively and in a solution-focused manner, including keeping management informed of potential issues.
Strong problem-solving skills and ability to troubleshoot quickly and implement solutions.
Excellent computer skills, especially with MS Office, MS Project, Master Control, document-sharing tools such as SharePoint and ShareFile, ERP systems such as SAP, and online and video-conferencing tools such as MS Teams.
Excellent written and oral communication skills.
Ability to work independently and manage one's time.
Familiarity with drug substance characterization analysis, including HPLC, UPLC, LC-MS, MS, GC-MS, AAA, and CHN.

Nice To Haves

Master's degree (M.S.) in Science or Engineering.
Ph.D. in a Science or Engineering field.
Portfolio Management Professional (PMP) certification.

Responsibilities

Represent Production as the subject matter expert on cross-functional customer project teams and ensure timely completion of project-related tasks within the operating line.
Manage sub-teams as needed and share responsibility for project success and key activities described in the PM guide.
Proactively communicate project scope changes to project leadership and business development or sales, and collaborate with customer SMEs and other cross-functional project managers to resolve product-related issues, including deviations, OOX, and scope changes.
Ensure ongoing production, analysis, and review are completed within production cycle times and committed QC and QA service processing times.
Map material and information flows in sufficient detail to measure task and group-task durations; develop strategies to reduce cycle and service processing times and keep functional end-to-end process mapping current and aligned with the Plan-to-Produce process.
Work with functional area managers and the scheduler to optimize the production schedule daily and keep projects aligned with timelines.
Use Huddles to communicate and consult with line functions, and ensure SAP OOP dates and batch information are kept up to date.
Drive process improvements, including revalidation and change implementation, to advance process knowledge.
Compile campaign reports after each production campaign using defined KPIs, trends, and lessons learned.
Maintain BoMs and recipes, and maintain the Master Batch Record after every campaign.
Coordinate with line functions to develop CAPEX investment proposals when needed to meet production objectives.
Prepare for and attend customer meetings, workshops, and visits to coordinate deliverables and support customer satisfaction.
Communicate customer needs and strategies to the production team, advocate for products, secure program resources and assets, and ensure departmental information flow to build and enhance customer relationships.