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Sr. Director/Director, External Manufacturing & Supply Chain

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Ohana Biosciences

Cambridge

Posted 584 days ago


Job Description:

Ohana Biosciences is seeking a highly motivated and accomplished individual to join us as Sr Director/Director, External Manufacturing & Supply Chain to drive operational excellence in the field of reproductive health.

In this role you will be hands-on reporting to the VP of Technical Operations and will define and shape Ohana’s external manufacturing strategy for biologics and medical devices.   You will develop the supply chain management strategic, tactical, and operational plans and processes to support Ohana’s clinical programs and first product launch.

What You’ll Do

●      Lead the CDMO selection process in collaboration with internal stakeholders, including developing and negotiating development, technology transfer, and manufacturing/supply contracts.

●      Manage the existing CMO/CDMOs and Packaging and distribution/logistics partners.

●      Establish governance structures (joint project teams, steering committee) that facilitate timely, open communication with CDMOs and internal stakeholders, and successful delivery of CDMO services.

●      Oversee and lead interactions with external manufacturing partners to assure on-time quality supply which meets compliance and regulatory requirements.

●      Assist in alliance development and management as needed.

●      Establish and manage the necessary manufacturing agreements including MSAs.

●      In partnership with the Quality organization, manage and ensure the timely review and release of product from external manufacturing partners.

●      In partnership with the regulatory function, manage the process improvement, update, and product launch as needed.

●      In partnership with commercial function, manage the demand and supply.

●      Author technical reports, manufacturing instructions, process validation documents, regulatory submissions and other technical and management documents as needed

●      Manage overall External Manufacturing and Supply Chain budget and spend, carefully balancing risk and cost.

●      Have responsibility for clinical supply continuity and risk management processes, including ownership of supply chain plans, inventories and forecast used to support clinical trials.

●      Collaborate with Clinical Operations to forecast initial and ongoing clinical drug supply needs and demand assumptions (enrollment rates, number of sites, number of countries etc.) and assure successful start-up of and distribution to clinical sites.

●      Manage the inventory of raw materials and starting materials used and produced internally and by our CDMO network, including tracking and managing supply and movement of materials across the manufacturing network.

●      Develop and maintain inventory management strategy and implement inventory tracking system.

●      Hire, lead, and develop employees to successfully meet group objectives.

What You’ll Bring

●      PhD with 12+ years of outsourced clinical and commercial biologics manufacturing and supply chain management experience in the biotech/pharmaceutical industry.  Non-PhD candidates with commensurate experience are welcome to apply.

●      Experience in managing outsourced device manufacturing and supply chain is desirable.

●      Track record of developing, negotiating, and administering clinical and/or commercial contract manufacturing agreements.

●      Strong knowledge and experience in designing and implementing outsourced manufacturing and supply chain best practices.

●      Deep familiarity in phase-appropriate cGMP quality systems with good understanding of regulatory requirements.

●      Firsthand experience in authoring and reviewing regulatory documents and participation in regulatory audits from agencies like FDA, EMA, PMDA, etc. is a must.

●      Strong technical leadership and expertise in upstream or downstream development, analytical development, and scale up of biologics. Experience with manufacturing technical support or manufacturing sciences and technical support organization is desirable.

●      Experience in handling and leading investigations, deviations, and quality events. Participation is CAPA, developing CAPA plans, audit reports, annual reports, validation plans, protocols, assessments, technical memo and other regulatory and quality documents etc.

●      Experience and comfort level with operating in early-stage clinical environments.

●      Intercultural experience and ability to operate and adapt in a complex and rapidly changing business environment.

●      Impeccable problem solving and collaboration skills with quality-driven mindset.

●      Proven ability to facilitate conversations and drive towards decisions. Ability to influence.

●      Proven ability to lead teams and develop individuals.

What We’ll Offer You

●      A dynamic work environment, with encouragement at all levels to take part in shaping Ohana’s culture and strategy for long-term success

●      Professional growth through mentoring, trainings and conferences, immersion in cross-functional projects as well as unique opportunities to learn and try new things at Ohana

●      Healthy on-site snacks for those of us in the office and free monthly lunches for those of us working remotely

●      Comprehensive, competitive healthcare (PPO) and dental coverage through Blue Cross Blue Shield, vision coverage through VSP, commuter benefits, generous family leave, paid time-off, 401k retirement plan with a match, disability & life insurance, and more.

Who We Are

At Ohana Biosciences, we are pioneering a reproductive health revolution through our industry-first platform of sperm-based technologies. We began with a vision to reimagine global reproductive health and help all people create the healthy family they dream of – when they are ready. Today, we believe our unprecedented understanding of sperm biology coupled with our pioneering research will turn our vision into a reality.

Through our platform, we are focused on fundamental components of reproductive health: fertility, pregnancy complications, inherited disease, developmental disorders, and non-hormonal contraception. By advancing research in fertility treatments, new technologies to reduce pregnancy complications, disease transmission, and developmental disorders, and enabling non-hormonal contraception, Ohana is dedicated to becoming a leader in reproductive health and offering life-changing options for people. Ohana was founded in 2016 by Flagship Pioneering and is based in Cambridge, Mass. For more information, please visit www.OhanaBio.com.

Our Values

Be Audacious

Traditional paths have put too much burden on women, not given men enough options, and leave too many people out. We take smart risks and fearlessly pursue our work to revolutionize reproductive health.

Stay Curious

Curiosity is what we live for at Ohana. We won’t achieve our mission unless we ask and answer thousands of questions about sperm biology and reproduction that have been ignored.

Be You

How great would it be if you could be yourself at work? That's what we want. That's what we need. From your interview to your 10th year at Ohana, we want you to be you—flaws and originality included. That's what makes us a family. We understand each other's strengths and weaknesses, and we work to support each other through anything.

We’re In It Together

You will never be alone at Ohana. Our name means family and that means we’re on this journey together. We support each other, recognizing each other’s contributions and encouraging each other’s career goals. Together we are elevated by the powerful work we do.

For more information please check out our website ohanabio.com.

Ohana is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Ohana, implied or otherwise. If you would like to develop a recruiting relationship with us, contact careers@ohanabio.com.

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