Production Project Manager

Bachem AG; 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

Diversity-friendly, equal opportunity

Job summary

Bachem is seeking an experienced Production Project Manager to lead cross-functional customer projects within the production line. You will act as a subject matter expert to ensure timely task completion and manage sub-teams as needed.

You will collaborate with customer SMEs and PMs to resolve product issues, drive process improvements, and maintain critical documentation like BoM and Master Batch Records after each campaign.

Qualifications

• Bachelor's Degree in Science or Engineering required.
• MS or PhD preferred or
• PhD in Science or Engineering field preferred
• 4-6 years experience in Biotech/Pharma/CMO with CMC knowledge of APIs
• 4-6 years excellent PM skills coordinating multiple programs and handling customer interactions
• Strong knowledge of chemistry, photosynthesis, and IND/NDA filings familiarity with CMC

Responsibilities

• Represent Production on cross-functional customer project teams as SME.
• Ensure timely completion of project tasks within the operating line.
• Update project leader on scope changes and deviations.
• Collaborate with customer SMEs and PMs to resolve product issues.
• Drive process improvements and revalidation as required.
• Compile campaign reports based on KPIs, trends, and lessons learned.
• Maintain BoM and Master Batch Records after each campaign.
• Propose CAPEX investments to meet production objectives when needed.
• Prepare for and attend customer interactions to coordinate deliverables.
• Advocate for the product and secure resources for programs.

Skills

Project management

Communication

Root cause analysis

Time management

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in Science or Engineering

MS preferred

PhD preferred

Tools

SAP ERP

MS Project

Master Control

SharePoint

ShareFile

MS Office

MS Teams

HPLC

UPLC

LC-MS

GC-MS

AAA

CHN

Job description

Select how often (in days) to receive an alert:

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.