Pharmaceutical Manufacturing Manager (1st Shift)
Company: Simtra BioPharma Solutions
Location: Bloomington
Posted on: April 1, 2026
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Job Description:
Simtra BioPharma Solutions (Simtra) is a world-class Contract
Development Manufacturing Organization, partnering with
pharmaceutical and biotech companies to bring their sterile
injectable products to market. With facilities in Bloomington,
Indiana, US and Halle/Westfalen, Germany, we offer a wide range of
delivery systems including pre-filled syringes, liquid/lyophilized
vials, diluents for reconstitution, powder-filled vials and sterile
crystallization. Our product types include biologics and small
molecules, cytotoxics, highly potent compounds, diluents for
reconstitution and vaccines – which are all directly injected into
patients worldwide. As such, there is a strong emphasis on quality
and continuous improvement at Simtra. We hold ourselves to the
highest quality and regulatory standards. While our primary focus
is cGMP manufacturing, we offer many support services including
formulation and development, lyophilization optimization, global
regulatory support and secondary packaging. Our teams are driven to
help clients scale, innovate and bring life-changing medicines to
patients worldwide. Why join Team Simtra? Because we: Make it
HAPPEN – We bring a growth mindset to every opportunity, developing
new skillsets and exceeding our expectations and those of our
customers. Make it TOGETHER – We work as one, respecting each voice
and tapping into our unique strengths across teams—so we can solve
problems in new ways. Make it RIGHT – We hold ourselves to a high
standard of excellence, fulfilling our commitments to the customer,
their patients, and our team members. 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. The role: The
Manufacturing Manager is responsible for all production activities
on a shift, supporting multiple filling lines manufacturing
injectable drug products. The Manufacturing Manager leads a team of
Manufacturing Supervisors and reports directly to the Senior
Manufacturing Manager (Building Manager). The manager will lead,
organize, and manage personnel and activities in all manufacturing
activities under cGMP regulations, to serve as the primary contact
for manufacturing related communications on the shift, and to
provide guidance to the leadership team to ensure consistent
execution and improvement of the manufacturing process. The
Manufacturing Manager creates an environment where teamwork,
productivity, safety, identity, strength, purity and quality
(SISPQ) are reflected in the finished product. Its
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. Provides timely and
accurate feedback recognizing good / poor performance. 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. Approves SOP’s, validations,
and protocols in a timely manner. Partners with client teams to
support client projects and client audits. Provide technical
expertise and resources, cooperating and coordinating with Quality,
Program Management, Engineering, Maintenance and Technical
Services. Ensures organization’s budget is met and maintains
expenses within the plan. Regularly interacts with senior
management and client representatives on matters concerning several
functional areas, divisions, and/or customers. Takes personal
responsibility to develop, deploy, and properly manage a culture of
safety and working conditions. Adheres to all environmental,
health, and safety SOPs and policies. Actions and decisions must
reflect that our team member’s safety is always first on our minds.
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. Must be a lean leader. Instills a culture of
“go and see”. Engage with team members where the work is done.
Embrace and adopt best practices. Setting the example is not the
only thing in influencing others, it is the main thing. Desirable
qualifications: Bachelor’s degree strongly preferred, with emphasis
on a scientific or engineering discipline. 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) Computer proficiency in Microsoft Word, Excel, and
Outlook and the ability to use enterprise software (examples
include: JDE, BPLM, MAXIMO, Trackwise, etc.) Physical / safety
requirements: Ability to stand for extended periods of time
Physical coordination/flexibility to allow gowning for clean room
environments Utilize applicable personal protective equipment,
including safety shoes/toe caps, gloves, eye protection, heat
resistant wear and hearing protection Dexterity and physical
condition to perform some level of repetitive motion tasks Ability
to wear respirator usage when product or task requires Duties may
require overtime work, including nights and weekends Use of hands
and fingers to manipulate office equipment is required Must be able
to gown qualify for Grade A/B areas (filling) Position may require
sitting for long hours In return, you’ll be eligible for [1] : Day
One Benefits Medical & Dental Coverage Flexible Spending Accounts
Life and AD&D Insurance Supplemental Life Insurance Spouse Life
Insurance Child Life Insurance 401(k) Retirement Savings Plan with
Company Match Time Off Program Paid Holidays Paid Time Off Paid
Parental Leave and more Adoption Reimbursement Program Education
Assistance Program Employee Assistance Program Community and
Volunteer Service Program Employee Ownership Plan Additional
Benefits Short and Long-Term Disability Insurance Voluntary
Insurance Benefits Vision Coverage Accident Critical Illness
Hospital Indemnity Insurance Identity Theft Protection Legal and
more Onsite Campus Amenities Workout Facility Cafeteria Credit
Union [1] Current benefit offerings are in effect through 12/31/26
Disclaimer This job description is intended to provide the minimum
knowledge, skills and abilities necessary to perform the job. It
may not be inclusive of all the duties and responsibilities of the
job. Simtra reserves the right to make modifications based on
business requirements. Equal Employment 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. Data Privacy To learn
more about Simtra's approach to data privacy, please review the
Simtra Recruitment Platform Global Privacy Policy:
https://simtra.com/privacy-policy/
Keywords: Simtra BioPharma Solutions, Terre Haute , Pharmaceutical Manufacturing Manager (1st Shift), Manufacturing , Bloomington, Indiana