Sr Manager, Operations Manufacturing

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Key Responsibilities

This role plays a vital part in supporting manufacturing and supply chain activities for both clinical and commercial products within a leading biotech organization. The position involves evaluating, selecting, and establishing relationships with Contract Manufacturing Organizations (CMOs) as part of the broader network. It also includes managing and providing leadership oversight for ongoing manufacturing programs. The role requires collaboration across the entire CMC (Chemistry, Manufacturing, and Controls) organization to coordinate with CMOs and other internal teams, including finance, contracting, and quality control.

The manufacturing and outsourcing team works across all stages of the product pipeline, from early-stage clinical batch production to scale-up and commercialization. This is a fast-paced and dynamic environment that demands a strategic mindset, operational expertise, and agility.

Key Duties:

• Lead and manage manufacturing programs for clinical and commercial stages, including the production of both drug substances and drug products.
• Oversee the selection and onboarding of contract manufacturing partners, ensuring they meet the organization’s standards and requirements.
• Serve as the main point of contact for external manufacturing organizations, managing relationships and ensuring project milestones are met.
• Establish technical, financial, and legal agreements with CMOs, ensuring clarity and alignment with the project’s goals.
• Collaborate with internal stakeholders, including CMC, finance, and quality teams, to ensure successful project delivery.
• Develop and manage project timelines, coordinating efforts between internal and external teams to ensure timely completion.
• Provide regular project updates to senior leadership, highlighting key achievements and addressing any challenges or risks.
• Escalate critical decisions and issues to senior management as needed to keep projects on track.
• Support the CMC team in preparing essential regulatory submissions, such as IND, IMPD, and BLA.
• Ensure clear communication and coordination between development teams, finance, and other key departments.
• Participate in managing cold chain logistics, ensuring the effective distribution of products between various suppliers and distribution points.

Skills & Experience:

• A strong background in CMC operations or manufacturing, within the biotechnology or pharmaceutical sector.
• Experience in managing relationships with Contract Manufacturing Organizations (CMOs) and overseeing their performance.
• Proven project management experience, particularly in managing multi-functional projects and working with cross-functional teams.
• Familiarity with regulatory requirements for biopharmaceutical products, including experience with submissions like IND, IMPD, and BLA.
• Strong organizational skills, with the ability to manage multiple projects and prioritize effectively.
• Excellent communication skills, both written and verbal, with the ability to engage and collaborate across different levels of the organization.
• A proactive, problem-solving mindset, with a strong ability to navigate complex challenges.
• Demonstrated ability to work within a fast-paced, highly collaborative environment.
• Experience with contract negotiation is desired.
• Willingness to travel up to 10-15% during peak times.

Education & Qualifications:

• Bachelor's degree in life sciences or a related discipline, with relevant industry experience.
• Advanced qualifications such as a Master’s, PhD, or PharmD in related fields are advantageous but not essential.
• PMP certification is a plus but not mandatory.

To apply, please submit your CV and please note all applications will be treated with the utmost confidentiality.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with businesses that promote DEI. We strive to create a welcoming and inclusive environment for all employees.