Simtra BioPharma Solutions
Pharmaceutical Manufacturing Manager, (2nd Shift)
Bloomington, Indiana, United States · Staff+
Sponsorship not specifiedDetected 12 days ago
ExcelGMPLeadershipCommunicationMicrosoft OfficeLean Manufacturing
About the role
- The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products.
- Provides timely and accurate feedback recognizing good / poor performance.
- Approves SOP's, validations, and protocols in a timely manner.
Responsibilities
- Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
- Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
- Interviews, hires, coaches, and develops staff.
- Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
- Develop, deploy, and properly manage processes to consistently "run the business" and "improve the business".
- Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
- Partners with client teams to support client projects and client audits.
- Ensures organization's budget is met and maintains expenses within the plan.
- Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- Ability to stand for extended periods of time
- Ability to wear respirator usage when product or task requires
- Use of hands and fingers to manipulate office equipment is required
- Must be able to gown qualify for Grade A/B areas (filling)
- Minimum 5 years' experience in all aspects of the aseptic pharmaceutical manufacturing process.
- Must have knowledge of GMPs and worldwide regulatory agency guidelines.
- Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
- Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
- Must be a lean leader.
- Computer proficiency in Microsoft Word,
Nice to have
- Bachelor's degree strongly preferred, with emphasis on a scientific or engineering discipline.
Benefits
- Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Adheres to all environmental, health, and safety SOPs and policies.
Company info
- Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
Equal opportunity
- Simtra is proud to be an equal opportunity employer.
- Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.