Production Project Manager

Bachem; Vista (CA); On-site; USD 104,000 - 142,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas is seeking a Production Project Manager to serve as the production SME on cross-functional customer project teams and to drive timely completion of project tasks within the operating line. You will coordinate sub-teams, communicate scope changes, and collaborate with the customer SME and other PMs to develop solutions for product-related issues, including deviations and changes.

The role requires 4–6 years in Biotech/Pharma with strong PM skills, and knowledge of CMC for APIs and

Qualifications

• 4-6 years in Biotech/Pharma/CMO with CMC API knowledge.
• Strong PM skills to coordinate multiple programs and customer interactions.
• Excellent presentation, communication, and root-cause analysis abilities.
• Familiarity with drug substance characterization analyses (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN).

Responsibilities

• Represent Production on cross-functional customer project teams as SME.
• Ensure timely completion of tasks within the operating line and manage sub-teams as needed.
• Update project leader and business development on scope changes and solutions.
• Coordinate with QA/QC to ensure cycle times and processing times are met.
• Prepare for and participate in customer interactions to align deliverables.
• Maintain BoM and Master Batch Records after campaigns.

Skills

Project management

Communication

Root cause analysis

Cross-functional coordination

Data analysis

MS Office

MS Project

SAP

Teams

Education

Bachelor's Degree in Science or Engineering

Master's Degree (M.S.)

PhD in Science or Engineering

Tools

MS Office

MS Project

Master Control

SharePoint/ShareFile

ERP SAP

MS Teams

Job description

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As the Production Project Manager, you will be represent Production on cross-functional customer project teams as the subject matter expert (SME). As a Production Project Manager, you ensure timely completion of project-related tasks within the operating line and manage sub-teams as needed. You proactively update the project leader and business development/sales on scope changes and collaborate with the customer SME and other cross functional PMs to develop solutions for product-related issues, including deviations, OOX, and scope changes. You share responsibility for the project's success and managing key activities as outlined in the PM guide.

What you will do

• Ensure ongoing production, analysis, review is performed within the cycle time (in production) and within the committed service processing time in QC and QA.
• Map processes (material and information flow) down to detail levels that allow the time needed for every task or group of tasks to be measured. Based on detailed mapping, develop strategies to reduce the cycle and service processing times, making sure that the functional E2E-process mapping is up to date and follows our Plan-to-Produce process.
• Consult and work closely with functional area managers and scheduler to optimize the production schedule daily, ensuring projects remain on track against project timelines. Utilize the Huddles to communicate appropriately and consult with the line functions, ensuring that SAP OOP dates and every batch are always updated.
• Drive process improvements, including revalidation and change implimentation as required to advance the knowledge space of the process.
• Compile campaign reports after every production campaign based on defined KPIs, trends and lessons learned.
• Accountable for BoM and recipe maintenance and is responsible for the Master Batch Record maintenance after every campaign
• In coordination with the line function, the PPM may develop proposals for CAPEX investments as needed, to meet production objectives.
• Prepare for and attend customer interactions (meetings, workshops and visits) to better coordinate key deliverables and ensure customer satisfaction.
• Serve as a crucial link, communicating customer needs and strategies to the production team, serving as the advocate for the product within the team, securing resources and assets for their programs, and ensuring information flow within the department to build and enhance the customer relationship.

Qualifications

• Bachelor's Degree in Science or Engineering (Chemistry, Chemical Engineering, Biochemistry, Biology or similar fields) required and
• Master's Degree M.S. preferred or
• PhD in Science or Engineering field preferred
• 4-6 years Experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs required and
• 4-6 years Excellent Project management skills able to coordinate complex activities of multiple program simultaneously, assist with customer interactions, good presentation and root cause analysis skills, to support investigations, ability to trend statistical data and good inderstanding of chemistry, photosynthesis required and
• Chemistry, Manufacturing, and Controls (CMC) knowledge associated with IND and NDA filings
• Effective interpersonal and facilitation skills and works well in a team environment
• Strong organization skills, attention to details, and ability to work in a fast-paced work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Strong problem solving skills and can quickly troubleshoot and implement solutions
• Excellent computer skills, especially MS Office, MS Project, Master Control, Document-sharing (SharePoint, ShareFile), ERP (SAP), online and video-conferencing meetings (i.e., MS Teams)
• Excellent written and oral communication skills
• Works independently and capable of managing one’s time
• Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN)

Base Annual Salary Range: $103,511 - $142,327

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The(a)in the job title stands forall. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.