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Danaher Corporation Assistant Manager of GMP Synthesis - Weekend Overnight in Coralville, Iowa

Reports to: Manager of GMP Synthesis

Employment Status: Exempt

Pay Assignment: M1 - Production Planning & Control

Location: Coralville

Division: Manufacturing Operations

Department: GMP Manufacturing

Group: GMP Synthesis

Shift: Friday, Saturday, Sunday 7:00P-8:00A

Summary:

The Assistant Manager monitors the daily operation of the manufacturing group and coordinates the hiring, training, and development of the staff.

The GMP Synthesis department must stay in sync with current good manufacturing practice (cGMP) requirement as prescribed by FDA Quality System Regulation (QSR) – including methods used in the implementation and control of manufacturing processes to produce oligonucleotides (a component to a medical device) for inclusion in in-vitro diagnostic test kits/systems.

Responsibilities:

  • Leads all aspects of daily workflow prioritization

  • Supervises the daily operations to ensure efficiency and accuracy of products according to customer requirements

  • Collaborates with other critical operational departments or groups to ensure product completion and answer questions.

  • Ensures finished products are delivered to the Shipping department on time.

  • Recognizes and troubleshoots process or instrument/equipment problems and serves as a troubleshooting resource to others.

  • Maintains, updates, and crafts new standard methodology documents and facilitates the associated training

  • Assists in the development of standard procedures used for customer-specific products as well as customer-specific documentation necessary to meet the customer’s requested specifications.

  • Ensures adherence to all departmental protocols, rules, and standard work

  • Assists in performing all day-to-day responsibilities of a Technician I and II, and Team Leaders, when needed to keep production moving.

  • Initiates Non-Conformance Reports (NCR), Deviations, and Production Change Orders (PCO) when needed

  • Completes Root Cause and Preventative action statements for Non-Conformance (NCR) and Corrective and Preventive Actions (CAPA)

  • Participates in customer and regulatory audits, customer visits and/or calls when required.

  • Assists in talent managerial duties such as timecard review, yearly performance reviews, career plan creation/discussions, hiring/interviewing, documentation of employee issues, etc.

  • Coordinates the cross-training of staff in other departments.

  • Monitors Key Performance Indicators for the group, documents, and takes action as necessary to correct negative deviations.

  • Communicates group needs to supervisor regarding quality, speed or cost potential improvements.

  • Represents group as a team member, as needed, on projects and new product implementation.

Education:

  • Associate’s (2 year) degree required

  • Alternately a combination of education and 2 years of experience will be accepted.

Required Experience:

  • Basic proficiency in Excel required

Nice to Have (NOT required) Experience:

  • Knowledge of ERP system (ex. SAP) preferred

  • Previous leadership experience preferred

  • Prior experience working in a high-pace production environment preferred

  • Understanding of Six Sigma Principles (Continuous Improvement, Culture of Quality, Lean, Root Cause Analysis, Value Stream Mapping, etc.)

Other Job Qualifications

  • Ability to facilitate communication between production personnel and management.

  • Ability to quickly prioritize and organize workload, based on multiple variables, in order to efficiently accomplish departmental goals

  • Ability to work independently

  • Ability to manage time well to achieve the best productivity possible

  • Ability to encourage and facilitate cooperation, teamwork, and pride.

  • Provides feedback and coaching to others

  • Acts as a resource in supporting the pursuit and review of career path progress.

  • Champions a continual learning environment

  • Adaptability to performing a variety of duties, often changing from one task to another without loss of efficiency or composure.

Physical Requirements:

Exert 20-50 lbs. of force occasionally and/or 10-15 lbs. of force frequently

What We Offer:

  • Generous Paid Time Off Accruals

  • 16 Hours PAID Volunteer Time Off

  • 10 Paid Holidays

  • Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

  • 401(k) with Company Match

  • Medical, Dental, and Vision Insurance Options

Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.

IDT is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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