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Assistant Manager of GMP Custom Formulations - Weekend Overnight

Location
Tama, Iowa
Job Type
Permanent
Posted
4 Sep 2022

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.

Job Title: Assistant Manager of GMP Custom Formulations

Location: Coralville, IA

Shift: Weekend Overnight (Friday/Saturday/Sunday 7:00pm - 8:00am)

Summary:

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

The GMP HPLC 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, primarily in with GMP Custom Formulations.

  • 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.

Nice to Have (NOT required) Experience:

  • Basic proficiency in Excel required

  • 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.)

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

  • 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.

When you join us, you'll also be joining Danaher's global organization, where 80,000 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 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 .

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@ to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

Apply for this job now

Details

  • Job Reference: 704004185-2
  • Date Posted: 4 September 2022
  • Recruiter: Integrated DNA Technologies (IDT)
  • Location: Tama, Iowa
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent