Leiters Health · 5 hours ago
Formulation Team Leader (2nd Shift)
Denver Metropolitan Area
Full-time
Onsite
Mid, Senior Level
2+ years expLeiters Health is a pioneering company in the pharmaceutical industry, dedicated to delivering high-quality compounded sterile products. The Formulation Team Leader is responsible for leading technicians during active manufacturing operations and ensuring compliance with production schedules and regulatory standards.
Health CarePharmaceutical
Responsibilities
Assist Manufacturing Supervisor in overseeing employees who are responsible for formulation or aseptic filling of sterile ophthalmic and injectable solutions
Collaborate with Manufacturing Supervisors to ensure completion of Formulation/Filling of products to meet scheduled release dates
Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, and accountability
Ensure training on SOPs and processes remains current
Ensure compliance with company policies, FDA regulations, safety standards, and GMPs
Collect data to support production efficiencies including processing time, downtime, and waste
Perform investigations, CAPA actions, and support deviation resolution for non-conformances in the manufacturing department
Work with QA to quickly resolve any variance or document errors so that product may be released on time
Lead trouble shooting and problem-solving activities in support of production operations
Support and participate in process improvement projects and initiatives for the manufacturing department
Support Supervisor in the management of daily staffing to meet the daily production schedule
Other duties as assigned
Qualification
Required
Associates degree or equivalent experience required
2+ years of manufacturing experience in a regulated environment required
Demonstrate exceptional organizational skills with the ability to manage multiple priorities, maintain attention to detail, and ensure timely completion of tasks and projects
Maintains a strong focus on achieving high-impact outcomes, setting clear goals, and driving performance in alignment with organizational objectives
Effectively brings cross-functional teams together, fostering a positive and inclusive environment that promotes teamwork, open communication, and shared success
Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is required
Proficient written, verbal and oral English communication skills are required
Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel
Preferred
1+ years in a leadership capacity
1+ years in an aseptic process environment
Benefits
Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
Dental & Vision insurance options including FSA & HSA
Employer Paid Life Insurance & Employee Assistance Program
Short Term & Long-Term Disability Insurance
Up to 4% 401K Matching (100% vested on day one!)
Generous Paid Time Off Options – vacation,sick, paid leave and holidays!
$5,250 Annual Tuition Reimbursement after 6 months
$1,000 Referral Bonus Program with no limit
Eligible for annual bonus program
Company
Leiters Health
Leiters Health is a trusted FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services.
201-500 employees
H1B Sponsorship
Leiters Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Growth StageTotal Funding
$35M2021-11-09Acquired
2020-12-15Seed
2019-01-01Debt Financing· $35M
Leadership Team
Joseph Cosgrove
President and Chief Executive Officer
Carie Edquist
Interim CFO
Recent News
2024-01-28
Specialty Pharmacy Continuum
2023-12-22
Company data provided by crunchbase