Production Manager

Orbis Clinical is seeking a Production Manager located in Noblesville, IN for a permanent position.

Summary of Position

• The Manager Production will work in a dynamic organization in the Operations team for North America. This role has the responsibility for supporting the on-time execution and delivery of sterile drug products including maintenance and reliability efforts. The Operations Manager will report to the Director of Operations.
• This role also has the responsibility for supporting and implementing projects related to our business strategy. More specifically, the responsibility and accountability of implementing New Product projects in support of our growth strategy in the leading edge of radiopharmaceutical diagnostic and therapeutic sterile drug products designed for critical-to-life indications.

Essential Functions

• Manage submissions and projects as assigned assuring compliance, planning, and execution.
• Process, interpret and provide recommendations for complex strategies.
• Critically review documentation for regulatory submissions and provide input for necessary revisions.
• Define Target Product Profile and build compliant drug and device “approvable” dossiers and registration.
• Serve as Liaison for third party service providers supporting Nuclear Medicine.
• Maintain associated compliance database for tracking individual and department project deliverables for New Submissions and RA Compliance.
• Implement policies, procedures, practices, and strategies for Regulatory Affairs.
• Develop and implement in alignment with regional RA taking local considerations into account.
• Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions.
• Execute objectives in alignment with Regulatory Head, Marketing and Global Business Units.
• Coordinate communication between the Global Business Units and the Regional Regulatory Affairs staff resulting in a collaborative relationship.
• Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards.
• Present to upper management at required intervals and effectively communicate successes and challenges.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor’s degree in Chemistry, Engineering or related field
• Seven years’ experience in pharmaceutical manufacturing with a minimum of five years of leadership experience
• Subject Matter Expert knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products
• Strong project management and organizational skills, including ability to work independently and as a team member
• Proven ability in setting priorities and organizing work to meet deadlines
• Proven experience in leading complex multi-discipline teams in a highly regulated environment
• Strong oral and written communication skills with proven ability to communicate effectively in high pressure environments 
• Ability to react to problems and lead the team to develop solutions while communicating effectively
• Ability to maintain collaboration in a results-driven environment
• Agile approach and willingness to learn new things – ability to work “on the fly” in a dynamic setting
• Experience with radiation safety programs preferred
• Lean and/or Six Sigma certification preferred
• Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
• Travel may be required up to 5% of the time

Working Conditions:

• Standard office environment, coupled with up to approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
• Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Willingness to work in a team-based environment. 
• Close attention to detail required. 
• May be required to stand or sit for long periods of time while performing duties. Must be able to stand 8+ hours a day.
• Responsibilities also include the ability to lift heavy objects (50 to 70 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach without accommodation. 
• Must possess good hand-eye coordination.
• Must be able to work outside of regular work hours and extended hours, including off shift, weekend, and holiday work as business needs require.
• Willingness to complete safety training within allotted timeframes, and ensure direct reports trainings and goals are completed and up to date.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $110,000 to $120,000 per year, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.