* Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
* On the job training / cross training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.
* Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
* Scheduled performance reviews create opportunities for advancement and pay increases.
* A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.
Responsibilities:
*Supervise the activities of production operators to ensure safe and compliant synthesis and/or cellular extraction of commercial oligonucleotides for Blood Screening Products.
*Responsible for responding to, addressing and providing guidance for production issues, safety incidences and/or personnel issues.
*Responsible for all regulatory compliance (e.g., ISO 13485, FDA, IVDR) activities for assigned area and assures group compliance to cGMP and regulatory requirements through monitoring, trending and auditing.
*Ensure safety and compliance regulations are enforced.
*Responsible for establishing and modifying the oligo synthesis (e.g., AKTA Oligopilot, HPLC systems) and/or production microbiology (i.e., BSL-2 and BSL-3 labs) production lines as a result of changing production needs and implementing process flow efficiencies/improvements.
*Responsible as Manufacturing liaison for Manufacturing Sciences in the development, validation and transfer of new or existing oligo synthesis and production microbiology products to internal and external manufacturing organizations.
*Follow established manufacturing procedures and good documentation practices.
*Ensure batch records, logbooks, inventory forms, in-process data spreadsheets and associated attachments are completed accurately and timely.
*Ensure applicable Change Control policies and procedures are followed for new or modifications to existing facilities, equipment and processes.
*Investigate assigned nonconformances/deviations in a timely manner to identify root cause and implement appropriate corrective and preventive actions.
*Gather and analyze Key Performance Indicator (KPI) data from production processes, labor utilization and environment to identify opportunities for continuous improvement and develop a culture of operational excellence.
*Develop and draft new SOPs and DMRs; modify or obsolete outdated/ineffective SOPs and DMRs when appropriate.
*Be a liaison to cross-functional partners (e.g., Supply Chain, Manufacturing Sciences, Manufacturing Technical Support, Quality Assurance, Quality Control, Validation, Facilities), promoting collaboration for organizational projects and goals.
*Ensure appropriate planning for successful execution of production activities, with efficient use of resources, to delivery products on-time in full.
*Ensure ERP (e.g., SAP) transactions are performed, reviewed and analyzed to ensure successful execution and continuous improvement of production activities.
*Mentor, train and develop personnel, as well as evaluate the effectiveness of training
*Assist Manufacturing Manager in defining individual and group goals.
*Monitor adherence to corporate training initiatives and requirements.
*Lead special projects, as needed.
*Support Manufacturing Manager for the preparation and subject matter expertise for regulatory audits (e.g., internal, notified body, regulatory authorities)..
*May support direct Manufacturing Operations, as needed.
Requirements:
*Bachelor's degree and 6+ years of related GMP experience in a laboratory or commercial manufacturing setting
*Master's degree and 4+ years of related GMP experience in a laboratory or commercial manufacturing setting
*2+ years of supervisory or team leadership experience
*Must have in-depth knowledge of commercial-scale manufacturing.
*Must have a thorough understanding of GDP, cGMP and ISO 13485 regulations as they apply to commercial-scale manufacturing.
*Must have direct experience with oligo synthesis equipment (e.g., AKTA Oligopilot, AKTA Pilot/Beckman Purification systems, Dionex/Vanquish HPLC analytical systems, rotary evaporators).
*Must have direct experience with cell culture, nucleic acid extraction and working in a BSL-2/BSL-3 laboratory.
*Must have prior experience in managing or establishing a chemistry/biology laboratory with all applicable safety control systems.
*Must be creative, highly organized, self-motivated, perceptive and innovative.
*Strong written and verbal communication skills.
*Must be able to handle multiple priorities and delegate responsibilities while maintaining quality.
*Must have excellent team building and/or leadership skills with small to medium-sized teams.
*Must have direct experience with Lean, 5S, and Operational Excellence.
*Must have experience with ERP systems (e.g., SAP) including goods movement transactions, inventory management, cost analysis, labor routings and data extraction.
*Must have experience drafting and revising SOPs and DMRs.
*Must have strong critical thinking skills, great attention to detail and be solution driven.
*Prior experience managing a diverse group of people with different strengths and skills is preferred.
*Prior experience in successful individual as well as team performance management is highly desired.
*Must be proficient using Microsoft Office software and tools.
*Must be flexible and willing to work evenings and weekends based on the production schedule needs.