Manager/Senior Manager, Quality Assurance

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Your Purpose

Alpha-9 Oncology is seeking a highly motivated Manager/Senior Manager, Quality Assurance with a strong GMP background to join our growing team. As a clinical-stage biotech focused on radiopharmaceutical innovation, we are looking for a hands-on quality professional who thrives in a small, dynamic environment and can support batch release for early-stage clinical programs.

Reporting to the Senior Director, Quality Assurance, you will play a key role in maintaining our GMP quality processes, ensuring compliance with regulatory requirements, and supporting clinical-stage manufacturing activities. This role will require strong collaboration with CDMOs and external partners to ensure quality standards are upheld. This role provides visibility and opportunities to professionally grow in the GxP QA area in addition to the primary responsibilities.

What You’ll Do

  • Serve as the QA subject matter expert for all CMC-related quality activities and collaborate with the CMC team on investigational product manufacturing/packaging and release, stability program, change management, vendor selection and GMP related audits.
  • Collaborate cross-functionally with CMC, clinical supply,  external manufacturing partners, analytical, and regulatory teams to ensure appropriate QA oversight for contract manufacturing, packaging/labeling and testing.
  • Support internal and external audits, including vendor qualification and regulatory inspections.
  • Support establishing and maintaining a ‘fit for purpose’ QA approach to GMP documentation such as SOPs, quality documentation, and GMP records.
  • Assist in training programs to foster a quality-driven culture across the organization.
  • Work closely with CDMOs and external partners to review documents and quality events to support clinical product manufacturing and testing.
  • Identify process improvement opportunities to enhance efficiency and compliance within the QA function.
  • Support CMC with metrics and trend review for ongoing just-in-time manufacturing activities.
  • Support the development and maintenance of the quality management system including but not limited to document management system, training, SOP development , Deviation and CAPA management.

 

What You Bring

  • Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field.
  • 5+ years of experience in a GMP Quality Assurance role within biotech or pharmaceutical manufacturing (early-stage clinical experience preferred).
  • Prior experience with radiopharmaceutical or other just-in-time manufacturing platforms is a plus.
  • Strategic and creative thinker, independent strong leader, and subject matter expert in cGMPS and a passion for driving a quality mindset across the organization.
  • Strong understanding of GMP regulations (FDA, EMA, ICH) and clinical-stage quality processes.
  • Experience with batch record review, release, and deviation investigations.
  • Experience working with CDMOs and external manufacturing partners.
  • Strong problem-solving skills and the ability to work independently in a fast-paced environment.
  • Effective communicator with a collaborative mindset and ability to work cross-functionally.

 

What we Offer

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

 

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.

Associate Director/Director, Corporate Strategy

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Your Purpose:

Alpha-9 Oncology is seeking a highly motivated Director of Corporate Strategy with a strong background in organizational leadership, strategic planning, and cross-functional collaboration to join our dynamic leadership team. In this role, you will work closely with the CEO, CBO, and Leadership Team (LT) to drive high-priority initiatives, ensure organizational effectiveness, and oversee critical corporate activities, including Leadership Team meetings and strategic projects. Reporting to the Chief Business Officer (CBO), you will play a pivotal role in shaping our corporate strategy, enabling streamlined execution of our mission and fostering a high-functioning organization. This position is based in our Boston office, with flexibility for hybrid work.

What You’ll Do:

  • Act as a liaison, sounding board, and implementer to the CEO and CBO; partner with the CEO and CBO on initiatives that ensure a high functioning organization.
  • Track high-priority initiatives for the CEO, CBO and LT and identify any obstacles; communicate initiative status, pulling in other leadership team members, as necessary.
  • Provide proactive support to the CEO and CBO through data gathering, information analyzing, and presenting considerations.
  • Maintain ongoing, regular stakeholder engagements with the leadership team to create a highly integrated organization and engage in coalition building to resolve challenges.
  • Plan, schedule and facilitate LT Meetings; prepare critical meeting agendas and send out pre-reads to attendees; capture major take-a ways, track outcomes and deliverables. and work with CBO and LT to ensure follow up and communication to a broader audience, as appropriate.
  • Ensure that LT meeting objectives are realistic, participants comprehend the level of preparation required, agenda items are prioritized, and time is appropriately allocated for discussion topics.
  • Support preparation for Board Meetings, Investor Meetings, and events.
  • Partner with program leaders, functional leaders, and administrative staff to ensure streamlined activities and the coordination and orchestration of projects or commitments directly involving the CEO and the LT.
  • Develop draft communications on behalf of the CEO and/or the LT.
  • Collaborate and partner with CEO’s Executive Assistant to remain apprised of/schedule upcoming CEO commitments.
  • Work independently and execute tasks with minimal direction, and through ambiguity.

What You Bring:

  • BS/BA degree in related discipline with 7 years or experience; MBA or advanced degree preferred coupled with 5 years professional experience in the life sciences sector strongly preferred.
  • Previous or similar experience preferred.
  • Strong ability to operate at a tactical, strategic, and operational level.
  • Excellent analytical skills and demonstrated strategic and organizational agility.
  • Proficiency in planning and project organization skills
  • Strong PowerPoint skills

What’s in it for you:

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

 

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.

Director/Senior Director, Clinical Supply Chain

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Your Purpose:

Alpha-9 Oncology is seeking a highly motivated Director/Senior Director, Clinical Supply Chain with a strong background in clinical supply strategy and radiopharmaceuticals to join our innovative organization. In this role, you will collaborate closely with cross-functional teams, including CMC, Clinical Operations, Regulatory Affairs, and Manufacturing, to drive the creation and execution of sourcing and clinical supply strategies across Alpha-9 studies and programs.

Reporting to the Chief Operating Officer, you will play a key role in shaping the clinical supply and isotope sourcing strategy and growing alongside a passionate team. You’ll have the chance to make a real impact on our mission while enjoying a dynamic work environment that fosters learning and career progression. This role is based in our Boston office with flexibility for hybrid work.

What You’ll Do:

  • Leads all aspects of the clinical supply team and studies/programs (as assigned).
  • Recruit, lead, and mentor direct reports, to ensure execution against short- and long-term objectives.
  • In collaboration with relevant internal partners, create finished drug product and radioisotope forecasts based on study and/or program needs to ensure optimized supply plan.
  • Oversee the team that ensures patient and manufacturing scheduling, ordering, tracking, delivery and receipt of clinical supplies at clinical sites within the US and ex-Us locations.
  • Identify and lead the evaluation of new potential suppliers or alliances in conjunction with cross-functional teams.
  • Develop isotope sourcing strategies in collaboration with CMC team.
  • Develop and manage the clinical manufacturing and isotope supply budget.
  • Develop and implement risk management strategies to mitigate supply chain disruptions.
  • Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases.
  • Facilitate the implementation of the IRT system for drug management.
  • Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
  • Actively participation in cross-functional meetings to ensure an executable supply chain strategy.
  • Maintain and monitor supply chain KPIs, evaluate to improve supply chain processes.
  • Available to be on-call outside of regular business hours to assist with any issues that may occur during weekend deliveries

What You Bring:

  • BS/BA degree in related discipline; MS/MA degree preferred.
  • 10+ years in pharma, biotech, or FDA-regulated industries, including 3–5 years of line management experience in Clinical Supply Management or a related field (equivalent education and experience considered).
  • Experience with radiopharmaceuticals or the distribution of Class 7 Dangerous Goods, including import/export, is a plus.
  • Solid understanding of and experience in pharmaceutical development, manufacturing, packaging, and labeling.
  • Global clinical trial experience across phases 1-3.
  • Strong organizational, leadership, and interpersonal skills, with the ability to effectively manage tasks, communicate across all levels, and drive projects to completion.
  • Ability to travel up to 25% (domestic and international).

What we Offer:

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

 

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.

Careers@Alpha-9 Oncology

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Explore Career Opportunities at Alpha-9 Oncology!

At Alpha-9 Oncology, we’re always looking for passionate and talented individuals who want to make an impact. If you don’t see a current opening that aligns with your skills and experience, we’d still love to hear from you!

By submitting your resume, you’ll be added to our talent network, and we’ll reach out if an opportunity arises that could be a great fit. With offices in Vancouver, Boston, and San Francisco, we’re growing and excited to connect with individuals who share our commitment to advancing cancer research.

If you’re interested in joining our team in the future, we encourage you to share your resume—we look forward to staying in touch!

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

 

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.