Commercial Manufacturing Team Leader

A brief overview

The Commercial Manufacturing Team Leader will lead a team composed of representatives from Manufacturing, Quality Assurance and Quality Control. The CMT Leader operates within a matrix reporting structure where team members maintain their functional reporting lines but are jointly accountable to the CMT Lead for project execution and deliverables. The CMT may lead 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 Leader is responsible for driving operational excellence and process innovation across Manufacturing, QC and QA. This role ensures that agreed standard cycle and service times are consistently met, while leading continuous improvement initiatives and maintaining end-to-end process visibility and control. 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. The CMT Leader fosters cross-functional collaboration. The position serves as a key interface between site-level execution and global product strategy.

What you will do

• Consult and work closely with functional area managers 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 weekly Site Scheduling Review meeting (SSR) to ensure that deliveries within the firm period are aligned with the production plan. Utilize the Huddles to communicate appropriately and consult with line functions 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.

• Prepare for and attend customer interactions (meetings, workshops and visits) to better coordinate key deliverables to 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 site, securing resources and assets for their programs, and ensuring information flow within the department to build and enhance the product deliverables are met on time, in full, with expected Quality all the time. Organize and support preparation for all business reviews.

• Control costs and monitor manufacturing financials performance by ensuring that production takes place within planned budgeted labor hrs, to ensure standard product cost remains on target. Conduct variance analysis on batches produced to ensure appropriate reserves are taken based on production variances if required. Ensure timely availability of starting materials for production. Accountable for Bill of Materials (BOM) and recipe maintenance and is responsible for the Master Batch Record preparation and maintenance after every campaign, and changes based on DCR, or MOCs required. Prepare standardized, streamlined campaign reports. Drive process improvements, revalidations, and changes within approved regulatory filing scope.

• 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.

• Map and optimize 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.

• Work within the cross functional CMT to communicate all deviations, delays to relevant supervisors and stakeholders, but also lead, own and manage 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. Coordinate daily priorities via Huddle Board meetings. Accountable for BoM and recipe maintenance and is responsible for the Master Batch Record maintenance after every campaign

• Leads escalation processes for issues that impact timelines, quality, or cost, ensuring timely resolution and transparency. The CMT will develop and 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 Leader may develop proposals for CAPEX investments as needed to meet production objectives. Develop strategic initiative concepts that may improve operations long term.

• Leverage Technical Operations support to provide Proactive Process Analysis trending that will seek to understand the stability of the process overtime and work closely with manufacturing to make improvement changes to ensure that the process operates with a CpK >1.33. Provide aggregated data for customers and Annual Product Quality Reviews (APQR). 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.

Qualifications

• Bachelor's Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field. 

• Master's Degree in related field (Preferred)

• PhD in related field (Preferred)

• 5-7 years proven experience in production, quality control, or quality assurance within pharmaceutical or chemical manufacturing environments. 

• 4-6 years experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs.

• Leading or contributing to operational excellence initiatives. Green Belt certification in Lean Six Sigma or equivalent (Preferred).

• Experience working in cross-functional teams and coordinating daily priorities.

• 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. 

• Excellent communication and cross-functional coordination skills. 

• 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) 

• 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: $114,306 to $157,199

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. 

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.