Manager, Raw Material & Microbiology

Our BusinessAdare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.”

Our CultureWhen it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.

Why Come to Adare?Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Position

Manager, Raw Materials and Microbiology

Location

Vandalia, Ohio

Summary

The Manager, Raw Materials and Microbiology is an essential part of the Site Quality team, and is responsible for the management of daily activities for the Raw Materials and Microbiology group.  The Manager will be expected to coach and mentor Raw Material Chemists and Microbiologists, provide input on resourcing, and prioritize tasks needed for the team to meet the established project timelines.

Responsibilities

Responsible for the operation of the personnel and equipment in the laboratory.  This includes personnel scheduling and ensuring all laboratory equipment is properly calibrated and functioning properly.

Creates training curriculum for staff member to ensure the team is properly trained.  

Guides team in troubleshooting and completing investigations and any significant deviations and/or OOS/OOT results.

Develops short and long term strategic plans

Develops and manages the budget.

Ensures the team complies with all safety regulations.

Responsible for performance appraisals of members of the group and for facilitating the career development of the team members through training, mentoring, etc.  

Reduces non-conformities and non-value added processes.

Participates in customer and regulatory audits.

Interfaces with Operations, Supply Chain, Technical Services, R&D and Regulatory Affairs to provide support as needed and assist with identification and resolution of problems related to Adare operations.

Proactively manage and mitigate risk across the raw material and microbiology processes.

Communicates customer, regulatory and organizational requirements to the team to assure product quality, compliance, and customer satisfaction

Understands, follows and enforces all established safety, health, quality GMP and Company policies, procedures and practices.

Approves method validation and verification testing on new products and raw materials for the Microbiology Lab.

Responsible for the approval of technical reports and other documents necessary for the completion of project goals and product compliance.

Other duties as required.

Experience, Education, and Skills Required

Minimum Bachelors degree in Analytical Chemistry or related scientific field.

8+ years experience in the Pharmaceutical industry, at least 5 years related to quality.

Previous experience directly managing teams.

Hands-on experience required performing the following types of testing:  Wet chemistry, HPLC analysis, GC analysis, UV analysis, titrations

The ability to evaluate results of HPLC, GC, UV, IR and wet chemistry techniques as applicable to a pharmaceutical lab environment 

Working knowledge of USP, EP, and JP procedures

Understanding of proper aseptic technique

Experience in reviewing and auditing Laboratory documentation required.

Computer skills regarding use and application of Microsoft Excel and Word required, Microsoft Access a plus

Strong technical writing skills, as well as organizational and project planning skills are required.

Interfaces with research and development personnel, manufacturing, quality control, customers, government agencies, and outside vendors and suppliers.

Confidentiality of projects, tests results and both customer and Company information and data is required.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLYNO AGENCIES OR THIRD PARTIES