Contract Technical Writer Jobs in Stevens Point, WI

Our Business
Adare 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 Culture
When 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

Senior Manager, Packaging Operations

Location

Philadelphia, PA

Summary

The Senior Manager, Packaging Operations is accountable for achieving the production schedules with focus on work quality and compliance.  The Senior Manager is a vibrant leader who is present on the production floor, and should create and maintain motivation and empowerment of team members, as well as promote a continuous improvement environment. Additionally, this Senior Manager is expected to oversee a team of technical writers within the department for documents such as Batch Records, SOP’s, work instructions and investigations. This role will also ensure thorough technical training of Packaging operators, line leads, and supervisors to ensure proper understanding of procedures and technical information.

Responsibilities

• Achieve the agreed manufacturing schedule through effective oversight of the packaging floor, and collaboration with Supply Chain and the Packaging Scheduler
• Facilitate Packaging department staffing meetings, generating action plans impacting Packaging departments KPI’s. Presents departmental metrics and action plans in management staff meetings.
• Coordinate with other departments (Manufacturing, QA/QC, Compliance, Validation, Product/Technical Development, Regulatory, HR, etc.), relevant regulatory agencies and outside contractors to resolve conflicts, potential problems, and ensure work orders and projects are successfully completed
• Actively coaches all team members promoting continuous improvement and overall team development and cross-training, including the Supervisory level.
• Interact with clients as needed
• Handle deviation investigations of high complexity when needed
• Directly manage and coach Packaging Supervisors and Packaging Quality Specialists (technical writers)
• Adhere to cGMP guidelines as well as the CFR.
• Maintain consistent and effective communication with Supervisors, Packaging support staff, and leadership.
• Provide continuous feedback and development opportunities relating to Supervisors and key personnel.
• Continuous analysis of current Packaging processes and procedures, proposals for improvements, implementation, and follow-through on agreed upon changes.
• Follow all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards.
• Continuous development, analysis and utilization of established departmental performance data programs to achieve departmental goals. Including future needs and capabilities.
• Understand implications of departmental downtime and inefficient processing.
• Contribute to Packaging planning and budgeting
• Perform other tasks as required.

Experience, Education, and Skills Required

• Bachelors degree in an engineering, mathematical, or life sciences discipline
• 5+ years’ experience in GMP Packaging environment
• Thorough knowledge of bottle and/or blister packaging, including experience with serialization
• 3+ years of formal people management experience
• Experience with resource planning in packaging or manufacturing
• Continuous Improvement and/or Lean Six Sigma experience
• Technical writing skills (i.e. Change Controls, Investigations or Protocols); deviation management, investigation writing and CAPA development
• Excellent interpersonal written and oral communication skills
• Proficient in Microsoft Office and general technical aptitude; working experience with ERP systems
• Strong analytical and problem-solving experience.
• Proven ability to motivate teams and manage conflict.

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 ONLY
NO AGENCIES OR THIRD PARTIES