Bachem

Develops and manufactures peptides and oligonucleotides

Production Project Manager

Project ManagementPosted on Nov 11

Full-timeVista, CA, USAIn-person

About the Job

Requirements

A Bachelor's degree in Science or Engineering, such as Chemistry, Chemical Engineering, Biochemistry, Biology, or a similar field, is required.
Four to six years of experience in the biotech, pharma, or CMO industry, with good knowledge of CMC development of APIs and KSAs, is required.
Four to six years of project management experience coordinating complex activities across multiple programs, supporting customer interactions, presenting, conducting root-cause analysis for investigations, trending statistical data, and understanding chemistry and photosynthesis, is required.
Knowledge of Chemistry, Manufacturing, and Controls (CMC) associated with IND and NDA filings is required.
Interpersonal and facilitation skills and the ability to work in a team environment are required.
Strong organizational skills, attention to detail, and the ability to work in a fast-paced environment are required.
The ability to communicate proactively and with a solution-focused approach, including keeping management aware of potential issues, is required.
Strong problem-solving skills and the ability to troubleshoot and implement solutions quickly are required.
Computer skills, especially with MS Office, MS Project, MasterControl, document-sharing tools such as SharePoint and ShareFile, ERP systems such as SAP, and online and video-conferencing meetings such as MS Teams, are required.
Excellent written and oral communication skills are required.
The ability to work independently and manage one's time is required.
Familiarity with drug-substance characterization analysis, including HPLC, UPLC, LC-MS, MS, GC-MS, AAA, and CHN, is required.

Responsibilities

Represent Production as the subject matter expert on cross-functional customer project teams.
Ensure timely completion of project-related tasks within the operating line and manage sub-teams as needed.
Proactively update the project leader and business development or sales on scope changes, and collaborate with the customer subject matter expert and other cross-functional project managers to develop solutions for product-related issues, including deviations, OOX, and scope changes.
Share responsibility for project success and manage key activities outlined in the project management guide.
Ensure ongoing production, analysis, and review are completed within production cycle time and within committed service-processing times in QC and QA.
Map material and information flows in detail so the time required for every task or group of tasks can be measured; use the mapping to 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 closely with functional-area managers and the scheduler to optimize the production schedule daily and keep projects on track against project timelines; use Huddles to communicate with line functions and ensure SAP OOP dates and every batch are updated.
Drive process improvements, including revalidation and change implementation, to advance process knowledge.
Compile campaign reports after every production campaign based on defined KPIs, trends, and lessons learned.
Maintain the bill of materials and recipes, and maintain the Master Batch Record after every campaign.
Coordinate with the line function to develop proposals for capital expenditure investments as needed to meet production objectives.
Prepare for and attend customer interactions, including meetings, workshops, and visits, to coordinate key deliverables and support customer satisfaction.
Communicate customer needs and strategies to the production team, advocate for the product within the team, secure resources and assets for programs, and ensure information flows within the department to build and enhance customer relationships.

Desired Qualifications

A master's degree in Science or Engineering is preferred.
A PhD in a Science or Engineering field is preferred.
A Portfolio Management Professional (PMP) credential is preferred.

A brief overview

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)
Portfolio Management Professional (PMP) preferred

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 for all. 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.

About the Company

Bachem

Develops and manufactures peptides and oligonucleotides

Bachem provides development and manufacturing of peptides and oligonucleotides for research, clinical development, and commercial products. Its offerings include custom synthesis and scale-up production, analytical testing, and related services across the drug development spectrum. Customers work with Bachem by specifying desired sequences and specifications, after which Bachem designs, synthesizes, and quality-controls the peptides or oligonucleotides and delivers them in appropriate scales and formats. The company differentiates itself through more than five decades of experience, a global footprint with sites in Europe, the US, and Asia, and an integrated set of services spanning discovery support to commercial manufacturing. Its goal is to help pharmaceutical and biotechnology companies advance peptide- and oligonucleotide-based therapies by providing reliable, scalable, and well-supported manufacturing and development capabilities.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Bubendorf, Switzerland
Founded: 1971

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