Commercial Manufacturing Team Member, Quality

Bachem; Vista (CA); On-site; USD 71,000 - 97,000; Full time

Benefits offered by this job

Competitive pay

Performance bonus

Medical/Dental/Vision coverage

401(k) with employer contribution

Paid vacation and sick days

Job summary

Bachem Americas is seeking a Commercial Manufacturing Team Member in Vista, CA. You will support planning, production and quality assurance activities across manufacturing, QA and QC to deliver products on time.

You will coordinate with the CMT Leader, monitor KPI dashboards, and help drive process improvements, CAPEX proposals, and OEE optimization within a fast-paced biotech environment.

Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• Master's degree MSc preferred or PhD in Science or Engineering preferred.
• 4-6 years proven experience in production, quality control, or quality assurance within pharmaceutical or chemical manufacturing environments.
• 1-3 years experience in Biotech/Pharma/CMO industry with knowledge of CMC development of APIs and KSAs.

Responsibilities

• Assist CMT to ensure ongoing planning, production, analysis and review is performed within cycle time and QC/QA service times.
• Learn material and information flows to ensure robust product cycles and update end-to-end process maps.
• Coordinate with Team Leader to optimize production schedules and communicate SAP OOP and invoicing dates to stakeholders.

Skills

Cross-functional coordination

Communication skills

Problem solving

Project management

GMP knowledge

Education

Bachelor's Degree

Master's degree MSc

PhD in Science or Engineering

Tools

SAP

LIMS

PowerBI

MS Project

Minitab

SharePoint/ShareFile

Job description

A Brief Overview

The Commercial Manufacturing Team Member is part of a team composed of representatives from Manufacturing, Quality Assurance and Quality Control. The CMT Member operates within a matrix reporting structure, where team members maintain their functional reporting lines but are jointly accountable to the CMT Leader for project execution and deliverables. The CMT may be tasked with one or multiple products, depending on the complexity of the commercial product(s). As new products (NCEs) transition from the product development phase to the commercial phase, with validation activities and filing completed, the CMT will serve as caretaker and process innovation driver of the product(s) to maximize output for peak performance. The CMT Member will assist in driving operational excellence and process innovation across Manufacturing, QC and QA. The remit of the CMT is to deliver on the value proposition potential of the product(s) by ensuring all aspects of the manufacturing and release processes are conducted to ensure Right First Time and in full delivery of the product(s) to downstream nodes.

What You Will Do

• Assist CMT to ensure ongoing planning, production, analysis and review is performed within the cycle time (in production) and within the committed service processing time in QC and QA.
• Learn material and information flows within the commercial setting to ensure robust and efficient product cycles. Maintain and update E2E-process mapping to ensure adherence to our Plan-to-Produce process while reducing the cycle and service processing times.
• Coordinate with Team Leader and schedulers to optimize the production schedule for their product(s), ensuring product demand remains on track against planned deliveries and commitment dates. Participate in the Huddles to optimize equipment usage to improve on OEE, ensuring that SAP OOP dates/ invoicing dates of all batches are always updated and clearly communicated to all stakeholders, including customers.
• Monitor key process data to ensure manufacturing remains in a controlled state. Drive process improvements, including revalidation and change implementation as required to advance the knowledge space of the process.
• Work within the cross functional CMT team to communicate all deviations, delays to relevant supervisors and stakeholders, but also assist in cross-functional investigations resulting from said deviations to ensure resolution and closure within a timely manner so as to maintain operations continuity and adherence to confirmed delivery dates. Understand daily priorities via Huddle Board meetings.
• Prepare for and attend customer interactions (meetings, workshops and visits) to better coordinate key deliverables to ensure customer satisfaction. Support preparation for all business reviews.
• Maintain a production dashboard that will be communicated weekly, biweekly or monthly, reflecting key performance indicators pertaining to the product(s) manufacturing performance.
• In coordination with the line functions, the CMT may develop proposals for CAPEX investments as needed to meet production objectives. Work with the CMT Leader to develop strategic initiative concepts that may improve operations long term.

Qualifications

• Bachelor's Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field required
• Master's Degree MSc preferred or
• PhD in Science or Engineering field preferred
• 4-6 years Years proven experience in production, quality control, or quality assurance within pharmaceutical or chemical manufacturing environments required and
• 1-3 years experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs required and
• Leading or contributing to operational excellence initiatives. Green Belt certification in Lean Six Sigma or equivalent is preferred and
• Experience working in cross-functional teams and coordinating daily priorities required and
• Experience with data analysis software such as Minitab, for data trending and KPI reporting
• Strong understanding of GMP and regulatory compliance & CMO business
• Proficiency in SAP, LIMS, and quality systems
• Familiarity with project planning tools and methodologies required
• Excellent communication and cross-functional coordination skills required
• 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 understanding of chemistry, and manufacturing. Peptide manufacturing knowledge preferred required
• Chemistry, Manufacturing, and Controls (CMC) knowledge associated with in-line products. Understanding of all key guidelines, ICHQ3C, Q3A, Q3R, Q7A, Q1, 21 CFR 514.8, etc.
• 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, Minitab, PowerBI, Master Control, Document-sharing (SharePoint, ShareFile), ERP (SAP), online and video-conferencing meetings (i.e., Skype)
• 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

$70,658 - $97,155

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.