About the role:

We are seeking an outstanding Senior Manager, Oligo NPI to join our process development team. The ideal candidate will have a strong operational and production background in the life science or diagnostic industries with prior knowledge of oligonucleotide manufacturing. In this role, the Senior Manager will be responsible for the setup and operation of a new Oligonucleotide manufacturing department. They will ensure that Safety, Quality, Cost and Delivery targets for this production unit are met; analyze and develop capacity and hiring plans; oversee the receiving end of new product introductions and daily production schedules. The role encourages early engagement with cross functional teams to influence optimal production processes.

What you will be doing:

• Establish new Oligonucleotide manufacturing department including:
  • Providing input on facilities requirements and equipment layout.
  • Managing the launch of new part numbers.
  • Ensuring appropriate batch records and work instructions have been drafted.
  • Hiring and training new Production Associates and Technicians.
• Create a facility and processes capable of producing individual bulk, stock plate based arrays, and custom one off panels of oligonucleotides.
• Building the finest team possible by recruiting the best, developing them to their highest potential and placing them in roles that will best leverage their strengths to serve the business needs.
• Ensuring daily production schedules and performance targets are met.
• Adhering to general safety rules, manufacturing procedures, company policies and procedures, QSR, and Good Manufacturing Practices.
• Leading and/or providing guidance and technical expertise for manufacturing related non-conforming material reports (NCMRs), customer complaints, and corrective and preventive actions (CAPAs) investigations as applicable.
• Driving employee development plans for progression and succession planning.
• Identifying potential issues upstream, downstream and within production processes, and initiating proactive improvements to eliminate or mitigate the situation - driving continuous improvement.
• Being the Manufacturing point of contact and a subject matter expert for new product introductions.
• Being the voice of the team supporting implementation and optimization of tools such as PLM, ERP and MES systems.
• Developing and managing budgets.
• Leading by example by being a positive, data driven, accountable role model for the team.

Minimum Requirements:

• 5+ Years as a Production Manager or equivalent.
• Minimum of 5 years in Oligonucleotide manufacturing.
• Degree in Biochemistry, Organic Chemistry, Chemical Engineering, or equivalent.
• Experience developing equipment and labor capacity models.
• Experience establishing department Key Process Indicators (KPIs) and using those metrics to drive continuous improvement.
• Strong understanding of Lean and/or Six Sigma principles.
• Successfully launched new products within manufacturing and/or started up new production processes.
• Experience in regulated settings (ISO 9001, ISO13485, FDA QSRs, etc.) strongly preferred
• Strong written and verbal communication skills.
• Ability to work independently managing and mentoring Manufacturing Supervisors and Associates.
• Capable of understanding and analyzing complex engineering and scientific problems.

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