MSAT Project Manager (Rare Diseases)

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 devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: MSAT Director Direct Reports: None Areas Managed: MSAT / Biologics Technology Transfer and Lifecycle Management

Overview

Primary: This role will provide technical support and product expertise to the MSAT team to assist with the technology transfer of commercial biologics manufacturing processes from external partners to new external CDMOs and partners.

Secondary: Additionally, the role provides support for life cycle management of Recordati's biological antibody products across multiple phases of development and therapeutic areas.

This role will involve working with global teams and external third-party networks. This is an individual contributor role with no line management responsibilities.

Reporting to the Director of MSAT, this role will allow the successful candidate to be a key player in securing the future supply of key biologics for the treatment of orphan indications and rare diseases. The role provides the opportunity to grow both technically and personally within a fast-paced, multi-functional environment. It is anticipated that the role will continue to expand and grow in responsibility with the expansion of Recordati's portfolio of products and may present opportunities to take principal responsibility for individual projects and activities.

As the successful candidate will be working with globally located CDMOs and partners, occasional travel may be required.

Key Responsibilities

Technology Transfer

• Lead technology transfer projects on behalf of Recordati, providing guidance and technical expertise to support operational technology transfer activities at CDMOs and partner organisations for long-term manufacturing and supply of biological products.
• Generate internal reports and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions and detailed gap assessments, as appropriate), ensuring all information is available to key stakeholders in RRD.
• Generate options to resolve technical challenges and present them for endorsement.
• Capture, trend and analyse process-generated batch data to support process improvements and life cycle management.
• Review manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, study protocols, SOPs, etc.) to ensure accuracy and suitability.
• Participate in, and where appropriate lead, technical sub-teams.
• Drive and maintain project progression with external and internal stakeholders.
• Inform and manage strategies for process characterisation/validation.
• Provide technical input into solution resolution for commercial processes and analytics, and into unforeseen events by engaging with the correct stakeholders to effectively resolve problems as they occur.
• Influence decisions while considering different functional department requirements.
• Coordinate, control and disseminate the flow of information to and from third parties and internal stakeholders.
• Proactively maintain and track actions, CMC, regulatory, financials, projected activities and requests across both internal and external stakeholders.

Manufacturing Process

• Demonstrate an understanding of biological USP, DSP and Drug Product manufacturing processes (ideally with experience in one or more pertinent fields, such as analytical and validation) technology transfers and CMC regulatory requirements.
• Network and develop authentic, high-performing working relationships, with the ability to express ideas and activities to a wide range of audiences and backgrounds.
• Operate strategically, ensuring project progression is performed holistically with the product and patient central to every decision and action.
• Coordinate effectively across multiple countries, territories, cultures and ways of working while meeting demanding timelines.

Quality Systems Requirements

• Maintain an understanding of current GMP manufacturing and regulatory frameworks. Comply with relevant RRD Pharma working practices and SOPs and relevant country codes, ensuring these standards are met across the organisation.

Education and Preferred Experience

• Minimum degree in a science-related field, preferably in a life science discipline.
• Minimum of five years of industry experience gained in a pharmaceutical-related field with exposure to biological products.
• Demonstrable experience working virtually and remotely is desirable.

Knowledge and Skills

• CMC-specific knowledge and a strong understanding of analytical methods, manufacturing, process development, quality control and quality assurance related to biologics.
• Experience in technology transfer of GMP biologics manufacturing processes.
• Experience in authoring reports, e.g., comparability reports and regulatory submissions.
• Ability to work in a fast-paced environment while retaining high attention to detail and quality.
• Experience working with and managing third-party manufacturing and testing partners.
• Understanding of process validation and the regulatory challenges required for the manufacture of commercial products.
• Excellent oral and written communication skills in English.
• Strong interpersonal, collaborative, problem-solving and conflict-resolution skills.
• Ability to develop solutions to technical and organisational issues to improve performance and productivity.
• Experience with budget management and oversight is an advantage.

Work Environment

This job operates in a professional remote office environment. This role routinely uses standard office equipment such as computers, phones, printers. Based upon job requirements, the employee may be required at times to attend meetings including travel out of state over weekends and nights. The employee must be able to freely operate and travel by car and train/plane modes of transportation. The employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those required to successfully perform the essential functions of this position. The employee must be able to travel domestically and internationally, as business needs require. This position is primarily sedentary.

The employee may occasionally move throughout office, meeting, or event locations and regularly operate a computer, telephone, and other office productivity equipment. The employee must be able to communicate effectively with internal and external stakeholders. Occasionally, the employee may be required to move or transport items weighing up to 25 pounds, with or without accommodations.

Location

• This position is based in office in Bridgewater, NJ USA or Hemel Hempstead UK
• The role will require travel to third-party partners based in Europe and the United States of America. Some international travel will be required from time to time, with total travel expected to be approximately 30%.

FLSA Classification

• This position is considered Exempt

EEO Statement

Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. 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 accommodation for qualified individuals 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.

• Base Salary Range: $120,640 to $180,960 USD annually. The base salary range represents the Company's good-faith estimate of the compensation range for this position at the time of posting.

• The actual base salary offered may vary based on factors including the candidate's qualifications, relevant experience, skills, internal equity, business needs, and geographic location, where applicable.

• Annual Incentive: This position is eligible to participate in the Company's annual bonus program, subject to the terms of the applicable plan and individual eligibility requirements.

• Benefits: Eligible employees may participate in a comprehensive benefits program, which currently includes medical, dental, orthodontia, and vision coverage; company-paid life and accidental death and dismemberment insurance; and short-term and long-term disability coverage.Retirement

• Savings: Eligible employees may participate in the Company's 401(k) retirement savings plan, subject to the terms of the plan.

• Paid Time Off: Eligible employees receive vacation, company holidays, and sick and personal time in accordance with Company policy and applicable law.

• The Company reserves the right to amend, modify, or terminate its compensation and benefit programs at any time, subject to applicable law.