{"id":3037206,"url":"https://alion.io/job/zymeworks-associate-director-downstream-process-development","title":"Associate Director, Downstream Process Development","company":{"id":179724,"name":"Zymeworks","domain":"zymeworks.com","url":"https://alion.io/company/zymeworks","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Rippling","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bellevue, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":136000,"max_usd":268000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":668},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-21T17:36:44Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-31T00:29:44Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"Company Description\nZymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore.\nWhy Work With Us\nNothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.\nThis role will be located in Bellevue and is hybrid with a minimum of 3 days per week onsite.\nWhat You'll Do\nServe as a strategic manager for the company’s downstream process development and production operations to drive program timelines.\nDirect the strategic planning of downstream process development and manufacturing in support of all phases of clinical development including support of late clinical phase filings.\nCollaborate within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for novel biotherapeutics and ADCs.\nLead project-specific efforts in process development, scale-up, production and tech transfer of processes within and between CMOs.\nParticipate in the development of RFP’s to solicit project specific bids from CMOs/CROs.\nDevelop SOWs defining work to be performed and provide subsequent oversight of experiments and activities conducted at the CMO/CRO.\nDevelop highly productive manufacturing processes in a timely manner for novel antibody, multispecific and ADC therapeutics. Brings issues to the attention of appropriate personnel as necessary.\nDesign, manage and support process characterization studies and develops control strategies for process validation.\nAuthor technical documents and deliver presentations to technical and project groups.\nContribute to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).\nWork directly with Research and Development, Analytic Sciences, and Technology and Quality teams to plan and implement execution of downstream process development and manufacturing operations.\nEnsure that all developed processes are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.\nServe as primary point of contact with contract manufacturing organizations (CMOs) and performs person-in-plant duties as needed to provide technical support for ongoing manufacturing.\nProvide technical support for all CMC activities, including investigations, CAPAs, Change Controls, technology transfers, operation and lifecycle management of pre-clinical and cGMP manufacturing processes, ensuring all product delivery schedules are met.\nAuthor and review technical CMC documentation, including protocols, technical reports, manufacturing batch records, SOPs, change controls and deviations.\nDrive timely decisions and facilitate active communication and information flow between CMOs and Zymeworks team members.\nFoster strong, long-lasting cross-functional working relationships with internal and external CMC, Quality Assurance, Project Management, Clinical Operations, and external manufacturing entities to ensure successful development and manufacture of all products.\nPromote a culture of continuous improvement in product quality and productivity.\nWork closely with all internal and external resources to ensure DS supply availability.\nWhat You'll Bring\nUniversity degree in science or engineering and a minimum of 8 years related experience in biopharmaceutical process development and GMP operations or an equivalent combination of education and experience.\nExperience working with contract manufacturing organizations.\nProven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.\nExcellent organizational skills and the ability to work effectively in a high paced, fast changing environment.\nConsistent analytical reasoning ability.\nFamiliarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus.\nStrong background in the regulatory compliance requirements for the cGMP production of biologicals for clinical and commercial use.\nWorking knowledge of regulatory guidelines and expertise in CMC, PK or toxicology for the advancement of therapeutics through different phases of development.\nProficiency with cGMP and ICH guidelines.\nTotal Rewards\nWe offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.\nThe base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).\nOur total rewards package that includes:\nIndustry leading vacation and paid time off\nExceptional medical, dental and vision benefits by country\nZymelife health and wellness benefits\nMatching RRSP / 401K / Pension program\nEmployee Share Purchase Program\nEmployee Equity Program\nPaid time off to volunteer in your community\nThis role is not eligible for relocation or immigration support.\nAll qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.\nNOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.","description_format":"text","description_chars":6850,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T21:43:20Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.855,"p_room":0.945,"age_days":8,"expected_fill_days":21,"reasons":["conf:3","win:mid"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/zymeworks-associate-director-downstream-process-development","json_url":"https://alion.io/job/zymeworks-associate-director-downstream-process-development.json","meta":{"generated_at":"2026-10-31T02:50:46Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":4005,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":179724},"rest":"https://alion.io/mcp/rest/get_company?id=179724"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fzymeworks-associate-director-downstream-process-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fzymeworks-associate-director-downstream-process-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fzymeworks-associate-director-downstream-process-development"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/zymeworks-associate-director-downstream-process-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fzymeworks-associate-director-downstream-process-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3037206}},{"tool":"search_jobs","arguments":{"company":"zymeworks.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3037206},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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