Pharmaceutical cGMP Production Manager

Job Title: Production Manager
Reports to: Site Manager / Chief Operating Officer
Hours: 8:30am-5:00pm (Standard hours added to match template)
Full Time or Part Time: Full-Time

Choice isnt optional. Its everything.

In how we fight for our future. But somewhere along the way medicine forgot that. Todays system runs on one-size-fits-all answers and a cold just take this mentality. Its efficient. Its easy. Its wrong.

EVEXIAS exists to blow that model wide open.

Were pioneering a new way of doing things and it starts by handing the decision back to the people who matter... you and your provider. TOGETHER you choose treatments tailored to your whole self: mind body and spiritincluding advanced personalized hormone therapies designed to restore balance and vitality.

We go beyond surface symptoms to uncover the root cause using todays breakthroughs to ignite a transition of modern medicinewhere insight runs deeper care is pro-active and connection is everything. We dig deeper. Treat smarter. And restore something even more powerful than health your Freedom. This isnt just healthcare. Its your comeback story and that story starts with a choice.

Get Well. Live Well.

Description

The Production Manager will oversee the daily manufacturing operations for our compounded pharmaceutical production lines. This role requires a leader who can thrive in a highly dynamic production environment while maintaining unyielding adherence to cGMP standards and FDA 503B regulations. You will bridge the gap between traditional compounding flexibility and industrial-scale pharmaceutical compliance ensuring that production targets are met without ever compromising quality. You will work closely with the Quality Unit to build a culture of continuous improvement proactive risk management and exact documentation.

Responsibilities

• Direct and manage all daily activities on the production floor including weighing milling blending granulation compression and packaging.

• Develop and execute dynamic production schedules to meet shifting market demands.

• Monitor production metrics (yield downtime cycle time) and implement corrective measures to ensure efficiency and cost-effectiveness.

• Oversee the management of production equipment and tooling including inspection maintenance and storage.

• Ensure all manufacturing activities strictly comply with 21 CFR Part 210 and 211 as well as specific 503B guidance.

• Ensure accurate contemporaneous completion and review of executed batch records logbooks and shop floor documentation in accordance with GDP and data integrity expectations.

• Partner with Quality on the revision implementation and continuous improvement of master batch records and manufacturing instructions.

• Collaborate with the Chief Quality Officer (CQO) and Quality Assurance team to investigate deviations implement Corrective and Preventive Actions (CAPAs) and resolve non-conformances.

• Lead or support manufacturing investigations related to deviations atypical events and batch failures ensuring timely root cause analysis and implementation of effective corrective actions.

• Monitor recurrence trends and implement sustainable process improvements to reduce repeat events.

• Ensure a state of continuous audit readiness for federal and state inspection walkthroughs.

• Promote adherence to data integrity principles across paper and electronic systems.

• Enhance production capabilities by hiring training and mentoring a team of production supervisors leads and machine operators (production technicians).

• Foster a Quality First culture on the floor encouraging the immediate reporting of near-misses and deviations without fear of retribution.

• Ensure all personnel adhere to strict gowning personal hygiene and safety protocols required for handling Active Pharmaceutical Ingredients (APIs) and operating heavy machinery.

• Conduct regular performance evaluations and build training matrices to ensure staff competency on complex equipment (e.g. tablet presses fluid bed dryers).

• Partner with Facilities and Maintenance Team to ensure all production equipment is calibrated validated and subjected to rigorous preventative maintenance schedules.

• Troubleshoot mechanical and processing issues on the floor to minimize downtime.

• Ensure proper line clearance and cleaning validation protocols are strictly followed to prevent cross-contamination between batches.

Qualifications

The ideal candidate will bring a strong engineering or scientific background alongside progressive leadership experience in pharmaceutical manufacturing specifically within solid dosage operations. Prior experience in an FDA-registered 503B Outsourcing Facility or a strictly regulated cGMP pharmaceutical manufacturing environment is required. This role requires an operational leader who can successfully collaborate with Quality Assurance teams troubleshoot complex processes and drive continuous improvement on the production floor.

Preferred Skills & Experience

• Bachelors degree in Engineering (Chemical Mechanical Industrial) Pharmacy Life Sciences or a related field (preferred).

• Minimum of 57 years of progressive leadership experience in pharmaceutical manufacturing specifically within solid dosage (tableting) operations.

• Deep technical understanding of the tablet manufacturing process (powder rheology compression dynamics tooling specifications etc.).

• Expert working knowledge of cGMP OSHA regulations and standard operating procedures (SOPs) implementation.

• Proven track record of successfully interacting with Quality Assurance teams and participating in FDA audits.

• Strong analytical problem-solving skills (Root Cause Analysis Fishbone 5 Whys).

• Experience with Lean Manufacturing or Six Sigma principles is highly preferred.

• Proficiency in ERP systems and electronic Quality Management Systems (eQMS).

• Ability to stand or walk for extended periods on the manufacturing floor.

• Must be able to wear appropriate personal protective equipment (PPE) and cleanroom gowning for extended shifts.

• Ability to lift up to 50 lbs and work around heavy machinery and loud noises (hearing protection provided when necessary).

• No known allergies to the APIs handled in the facility.

Comprehensive Benefits Package

We are committed to supporting our teams health financial future and work-life balance. Our benefits include:

• Healthcare Coverage: Comprehensive health dental and vision insurance plans with company-subsidized premiums.

• Peace of Mind: 100% company-paid Short-Term Disability (STD) Long-Term Disability (LTD) and Life Insurance.

• Retirement Savings: A 401(k) plan featuring a 4% company match to help you build for the future.

• Work-Life Balance: Generous Paid Time Off (PTO) so you can relax recharge and take care of what matters most.

Our Mission

To empower individuals and providers with personalized root-cause-focused care that restores health balance and freedom.

Our Vision

To lead a transformative shift in modern medicinewhere deeper insights proactive care and personal choice define the future of wellness.

Our Values

• Care: We provide a welcoming nurturing environment for our staff and our clients.

• Growth: We are dedicated to fostering beneficial change for ourselves and those we serve.

• Respect: We are unwavering in our commitment to speak with honor and listen without judgement.

• Partnership: Working collaboratively to build trust value diverse perspectives and achieve shared goals.

• Integrity: Acts with honesty accountability and alignment to company values.

Your career in pharmaceutical innovation starts here!

The Fine Print:

FARMAKEIO Equal Employment Opportunity (EEO) Statement

FARMAKEIO is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We comply with all applicable federal state and local fair employment laws ensuring equal employment opportunities for all employees and decisions at Evexias are based on qualifications merit and business needs. We do not discriminate on the basis of race color religion sex (including pregnancy childbirth and related medical conditions) sexual orientation gender identity or expression age national origin disability genetic information marital or familial status military or veteran status citizenship status creed domestic violence victim status caregiver status or any other characteristic protected under applicable laws.

This policy applies to all aspects of employment including recruitment hiring training compensation benefits promotions transfers terminations and other terms and conditions of employment.

FARMAKEIO is dedicated to maintaining a workplace free from discrimination harassment and retaliation ensuring a respectful and inclusive environment where all employees can thrive.

If you require a reasonable accommodation during the application process or in your role due to a disability or any other protected status please contact for assistance.

Texting Privacy Policy and Information:

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