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Sr. Manager / Manager External Manufacturing Technical Operations

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Ohana Biosciences

Cambridge

Posted 584 days ago


Job Description:

Ohana Biosciences is seeking talented Sr. Manager/Manager External Manufacturing Technical Operations to drive outsourcing collaborations and supply chain in the field of reproductive health.

As the Manager/ Sr. Manager, External Manufacturing Technical Operations, you will be responsible for planning and execution of Technical Operations projects, coordinating with internal cross-functional teams and external CMOs. You will drive technical support and oversee drug supply, material planning for commercial product as well as developmental projects with our CMOs/CDMOs in field of biologics and medical devices.

What You’ll Do

●      Provide oversight to manufacturing collaborations, scheduling, and planning.

●      In conjunction with Head of External Manufacturing, support Tech-transfer / Design transfer activities for Drug Substance, Drug Product, Finished Product and Distribution to contract manufacturing organizations and alliance partners.

●      Be responsible for product supply planning, for commercial product and developmental projects with our CDMOs.

●      Drive planning and execution of CMC projects, coordinating with internal cross-functional team and external CDMOs

●      Collaborate with quality and regulatory functions to make sure supply is secured and de-risked.

●      Establish and track schedules, resource needs, budgets, and project plans with buy-in from internal and external stakeholders.

●      With the support of program management, identify CMC project critical path and propose risk mitigations to keep programs on track.

What You’ll Bring

●      PhD with 8+ years of experience in a Pharmaceutical, Biotech, and/or combination products. Non-PhD candidates with commensurate work experience are welcome to apply.

●      Experience with supply chain management of Drug Substance, Drug Product and Finished Goods in the fields of biologics and medical devices.

●      Proven experience in leading relationships with outsourced service providers to support product supply objectives.

●      Experience with monitoring performance metrics and helping to set and execute various supply chain strategies while monitoring inventory levels of commercial supplies, key components, and raw materials.

●      Strong CMC project management skills with experience managing a CMC projects.

●      Ability to manage cross-functional working teams to develop and meet timelines, assess and mitigate project risks, and track project costs.

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

●      Excellent communication skills with experience presenting project status and forecasting progress towards key milestones.

●      Strong understanding of biologic Drug Substance, Drug Product and Finish Product development and scale-up is a must.

●      Experience in handling/participating 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 working cross functionally in a GMP/ISO 9001:2008 setting with internal and external CDMOs.

●      Demonstrated knowledge of GMP, QSR, and ISO 13485, 21 CFR part 11.

●      Experience in authoring and reviewing regulatory documents and participation in regulatory audits from agencies like FDA, EMA, PMDA, etc. is desirable.

●      Collaborative attitude with a strong work ethic and self-motivation necessary to thrive in an entrepreneurial and multidisciplinary environment.

●      Ability to think critically and creatively.

●      High level of adaptability and responsiveness to technical and business opportunities and needs.

●      Comfort handling parallel tasks and large datasets and delivering within fast-paced deadlines.

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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