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Associate Director, Downstream Process Development & Manufacture

674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001 · Lexington, MA, US, Lexington, MA · Deleted · $190,000–$205,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
TitleAssociate Director, Downstream Process Development & Manufacture
Normalized title-
Department / team-
LocationLexington, MA, United States
Work model-
Employment typeFull Time
Salary$190,000–$205,000 / year
Statusdeleted
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-03-04 / 2026-05-31
Changed / last seen2026-06-12 / 2026-06-10

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Linked records

Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
Source4f2fb43e-6107-4f34-ab57-87d29ca5c68a
ATS providerADP Workforce Now Recruiting

Description

Kiniksa Pharmaceuticals is a commercial stage, publicly traded biopharmaceutical company with the mission to help patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s portfolio of assets, includes ARCALYST® (rilonacept), which was approved by the FDA in 2021, as well as other clinical assets that are based on strong biologic rationale or validated mechanisms. The company is led by an experienced management team with a history of success and is well-capitalized with a top tier institutional shareholder base. Reporting to the Exec. Director of Drug Substance Process Development and Manufacture, the associate director, Downstream Process Development and Manufacture will be responsible for managing and supporting the downstream development and manufacturing activities of late-stage programs, including process development, tech transfer, GMP manufacturing, on floor support, process characterization, process validation, Life cycle management, and BLA-enabling studies. It extends further to the preparation of CMC content for regulatory submissions and correspondences. The incumbent will oversee the planning and execution of outsourced CMC activities, and work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality, timeline and budget. S/he will contribute to the identification and selection of CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. S/he will also manage the tech transfer activities between various manufaturinfg sites and work with internal lab to design and coordinate development studies. This role is based in our Lexington, MA office. Job Responsibilities (including but not limited to): Manage and support downstream development and manufacturing activities of late stage programs, including process development, tech transfer, GMP manufacturing, process characterization, process validation, life cycle management, and BLA-enabling studies Manage and support tech transfer activities between various manufacturing sites and provide on floor support during GMP manufacturing operations Collaborate with internal lab to design and execute development studies Provide technical input for the development and scale up of robust downstream processes Author and review CMC documentation for regulatory filings, as needed Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development Apply innovative technical ability and knowledge to critically analyze experimental data and results Set clearly defined goals/objectives to ensure delivery of high-quality results Provide clear communication to functional line management and cross-functional teams regarding progress against technical objectives/milestones Ensure well-organized, clear and complete records of all activities across areas of responsibility Approximately 5-10% of domestic and/or international travel Qualifications and Experience Ph.D. in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) with 5+ years of biologics drug development experience in pharma/biotech, or MS with equivalent education with 7+ years of biologics drug development experience in pharma/biotech Experience in the areas of downstream process development and process characterization based on quality by design (QbD) principles Expert knowledge of protein purification unit operations and process technologies (e.g., centrifugation, filtration, chromatography, etc.) and experience in advancing biologics processes through clinical development to successful regulatory approval/licensing. Knowledge of and experience with production of recombinant proteins using mammalian cell lines. Experience and knowledge in process validation preferred Excellent communication and interpersonal skills fostering team spirit Strong technical/analytical skills to identify and solve problems Self-motivated, assertive, and self-confident with the ability to act with urgency and passion Proven ability to manage projects and work with a high level of integrity, accuracy, and attention to detail Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on time and on budget Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making Resourceful, creative, enthusiastic, and results-oriented Salary is commensurate with experience. Kiniksa Benefits Summary - USA The expected salary range for Associate Director, Downstream Process Development and Manufacture is $190k-205K annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks. Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Full job record

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TitleAssociate Director, Downstream Process Development & Manufacture
Normalized Title—
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First Seen At2026-05-31 18:30:04Z
Last Seen At2026-06-10 12:09:54Z
Last Checked At2026-06-12 12:13:15Z
Last Changed At2026-06-12 12:13:15Z
Inactive At2026-06-12 12:13:15Z
Source Posted At2026-03-04 16:09:00Z
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    "requisitionDescription": "<div><div><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;vertical-align:baseline;' data-pasted=\"true\"><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">Kiniksa Pharmaceuticals is a commercial stage, publicly traded biopharmaceutical company with the mission to help patients suffering from debilitating diseases with significant unmet medical need. Kiniksa&rsquo;s portfolio of assets, includes ARCALYST&reg; (rilonacept), which was approved by the FDA in 2021, as well as other clinical assets that are based on strong biologic rationale or validated mechanisms. The company is led by an experienced management team with a history of success and is well-capitalized with a top tier institutional shareholder base.&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">Reporting to the Exec. Director of Drug Substance Process Development and Manufacture, the associate director, Downstream Process Development and Manufacture will be responsible for managing and supporting the downstream development and manufacturing activities of late-stage programs, including process development, tech transfer, GMP manufacturing, on floor support, process characterization, process validation, Life cycle management, and BLA-enabling studies.&nbsp;</span><span style=\"font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">It extends further to the preparation of CMC content for regulatory submissions and correspondences.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:11.7pt;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">The incumbent will oversee the planning and execution of outsourced CMC activities, &nbsp;and work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality, timeline and budget. S/he will contribute to the identification and selection of CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. S/he will also manage the tech transfer activities between various manufaturinfg sites and work with internal lab to design and coordinate development studies.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:11.7pt;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">This role is based in our Lexington, MA office.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Job Responsibilities&nbsp;</strong><strong><em>(including but not limited to):</em></strong></span></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Manage and support downstream development and manufacturing activities of late stage programs, including process development, tech transfer, GMP manufacturing, process characterization, process validation, life cycle management, and BLA-enabling studies</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Manage and support tech transfer activities between various manufacturing sites and provide on floor support during GMP manufacturing operations</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Collaborate with internal lab to design and execute development studies</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Provide technical input for the development and scale up of robust downstream processes</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Author and review CMC documentation for regulatory filings, as needed</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Apply innovative technical ability and knowledge to critically analyze experimental data and results</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Set clearly defined goals/objectives to ensure delivery of high-quality results</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Provide clear communication to functional line management and cross-functional teams regarding progress against technical objectives/milestones</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Ensure well-organized, clear and complete records of all activities across areas of responsibility</li><li style=\"margin: 0in; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 18pt; background: white;\">Approximately 5-10% of domestic and/or international travel</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:.5in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:.5in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\"><strong>Qualifications and Experience</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ph.D. in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) with 5+ years of biologics drug development experience in pharma/biotech, or MS with equivalent education with 7+ years of biologics drug development experience in pharma/biotech</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience in the areas of downstream process development and process characterization based on quality by design (QbD) principles</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Expert knowledge of protein purification unit operations and process technologies (e.g., centrifugation, filtration, chromatography, etc.) and experience in advancing biologics processes through clinical development to successful regulatory approval/licensing.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Knowledge of and experience with production of recombinant proteins using mammalian cell lines.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience and knowledge in process validation preferred</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Excellent communication and interpersonal skills fostering team spirit</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong technical/analytical skills to identify and solve problems</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Self-motivated, assertive, and self-confident with the ability to act with urgency and passion</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Proven ability to manage projects and work with a high level of integrity, accuracy, and attention to detail</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on time and on budget</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Resourceful, creative, enthusiastic, and results-oriented</li></ul></div><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 12.1pt; background: white;\">Salary is commensurate with experience.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0); line-height: 12.1pt; background: white;\"><strong><a href=\"https://www.kiniksa.com/join-us\" target=\"_blank\" style=\"font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Kiniksa Benefits Summary - USA</a></strong></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">The expected salary range for Associate Director, Downstream Process Development and Manufacture&nbsp;</span><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">is $190k-205K annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; color: rgb(0, 0, 0); font-size: 14px;\">Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</span></p></div></div>\n",
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