Associate Director, Technical Operations, Manufacturing

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To:    Head Industrial Operations, NA
Direct Reports:    Global Contract Manufacturing Manager
Areas Managed:    Manufacturing , CMO relationship management

Overview

The Associate Director of Technical Operations, Manufacturing provides direction of Recordati Rare Diseases product portfolio to include operations management and oversight for external biopharmaceutical and small molecule contract manufacturers of API and drug products worldwide. He/she is responsible for supporting the commercial product disposition activities as well as deviations, CAPAs, and change controls that are associated with products manufactured at external contract manufacturers to ensure the contract manufacturer meets health authority expectations regarding the manufacture of RRD products.  This position manages relationships with contract manufacturing partners and ensures that outsourced manufacturing operations meet established standards and specifications for quality and timeliness.  He/she devises strategies which ensure that products adhere to Recordati quality standards and all regulatory requirements. He/she directs and monitors environment for continuous improvement opportunities in manufacturing operations. Finally, this position will establish and lead a team-based collaborative environment that promotes commitment to continuous improvement and the achievement of business goals.

Essential Duties and Responsibilities

•    Direct activity and lead technical initiatives with external suppliers and collaborative partners by managing cross-functional projects.  Leverage extensive experience to influence the commercial and technical operations networks.
•    Serve as a technical subject matter expert (SME) in support of external supply operations, worldwide applying advanced theory, technical principles, and expert judgment.
•    Provide technical expertise/support for the development and design of pharmaceutical processes, equipment, and facilities using new or existing technologies.
•    Direct the transfer of new or existing products and processes from innovator sites to RRD external suppliers.
•    Responsible for leading complex troubleshooting processing, equipment, and product problems through critical analytical thinking and a "hands-on" approach. 
•    Identify, develop, and implement new manufacturing system technologies, novel ideas, or innovative approaches that make a major scientific or technical advancement with collaborative partners.
•    Responsible for the identification, development, and implementation of new manufacturing system technologies, novel ideas, or innovative approaches that make a major scientific or technical advancement with collaborative partners.
•    When requested/assigned, oversee process fits when examining alternative solutions to RRD strategies such as capacity expansion, manufacturing rationalization, compliance issue resolution, potential asset acquisitions, and due-diligence assessments of licensee or collaborative initiatives with RRD Business Development group. 
•    Provide project coordination leadership for multi-disciplinary teams, including product site transfer, new product realization, process development, problem resolution, and capital project management at external suppliers. 
•    Represent Manufacturing on cross-functional teams throughout the product lifecycle to support relevant Chemical, Manufacturing and Control (CMC) development requirements, launch new products, meet supply needs, and manage required change control.
•    Lead and/or participate in process improvement initiatives to improve product quality, robustness, and process capability for externally manufactured products.
•    Provide technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observations, and all processing issues.
•    Manage the process validation lifecycle, technology transfers and process capability procedures, providing training as needed to the External CMO team and ensuring implementation.
•    Participate in industry and regulatory conferences to benchmark industry trends, best practices, and regulatory expectations, both domestically and internationally. 
•    Actively promotes a healthy climate of communication, including information handling, sharing, inclusion, and goal alignment.
•    Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
•    Perform additional duties as may be assigned.

Education and Experience

•    Masters in Chemistry, life sciences or Engineering preferred.
•    Minimum of 10 years relevant experience with technical and quality operations within a pharmaceutical, biotech or contract manufacturing firm.
•    Strong project management experience required, PMP certification preferred.
•    Experience with regulatory authorities preferred.
•    Statistical knowledge required, Lean/Six Sigma Certification preferred.
•    Demonstrated career progression in roles of increasing responsibility in operations and/or pharmaceutical technology.      

Knowledge and Skills

•    Advanced technical knowledge in the field and the ability to be creative and imaginative in the approach to new and diverse problems. 
•    Thorough understanding of process validation concepts and experience with technical transfer.
•    Experience in the manufacturing of Biologic products is preferred
•    Demonstrated leadership and teamwork skills; demonstrated ability to integrate activities of cross-functional team and among collaborative partners.
•    Strong interpersonal skills, strong customer-focus given the need to integrate activities with cross functional and collaborative partners.
•    Working knowledge of pharmaceutical and biotechnical manufacturing processes.
•    Working knowledge of FDA, cGMPs and New Drug Application (NDA) requirements.
•    Solid communication skills, including the ability to write clearly and succinctly.
•    Demonstrated ability to exercise influence without authority.
•    Organizational skills and the ability to manage multiple project streams simultaneously.
•    Strong analytical skills.
•    Interpersonal skills and demonstrated ability to establish and maintain effective relationships with team members.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.  Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation.  Employee is required to have a valid driver’s license and means of transportation. Employee must be able to meet gowning requirements in place at CMOs that may include clean rooms and controlled environments. 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.  This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    This position is based at RRD’s North American Headquarters in New Jersey.
•    Approximately 30-40% of travel required.

FLSA Classification

•    This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodate for qualified individual with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

Disclosures

Base Pay Range: $122,000 to $183,000 per year. Other Compensation: This position is eligible to participate in the Sales Incentive Plan.Health and Insurance Benefits: Comprehensive medical, dental, orthodontia, and vision coverage; company-paid life and AD&D insurance; short-term and long-term disability benefits.Retirement Benefits: Eligibility to participate in the company’s 401(k) retirement savings plan.Paid Time Off: Vacation, company holidays, and sick/personal time provided in accordance with company policy and applicable law.