Commercial Manufacturing Team Member - Quality Assurance

Bachem•Vista, CA

46d

About The Position

The Commercial Manufacturing Team(CMT) 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 member 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 member 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 QA along with Manufacturing and QC. The remit of the CMT member 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.

Requirements

Bachelor's Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
4-6 years Years proven experience in Quality Assurance within pharmaceutical or chemical manufacturing environments
1-3 years experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs.
Proficiency in LIMS and quality systems.
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.
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
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)

Nice To Haves

Master's Degree in related field (Preferred)
PhD in related field (Preferred)
leading or contributing to operational excellence initiatives. Green Belt certification in Lean Six Sigma or equivalent (Preferred).
Portfolio Management Professional (PMP) (Preferred)

Responsibilities

Assist the CMT Leader to ensure ongoing planning, production, analysis and review is performed within the cycle time (in production) and within the committed service processing time in Quality Assurance.
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 the 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 group 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.