SR. MANAGER / ASSOCIATE DIRECTOR MANUFACTURING – BRIS.108

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[av_heading heading=’Sr. Manager/Associate Director Manufacturing’ tag=’h1′ style=’blockquote modern-quote modern-centered’ size=’32’ subheading_active=” subheading_size=’15’ padding=’10’ color=’custom-color-heading’ custom_font=’#6a8494′]
Chief Executive Officer
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Sr. Manager/Associate Director Manufacturing

Summary

The Sr. Manager/Associate Director Manufacturing gives oversight to and management of Starting Material, Drug Substance, Drug Product contract manufacturing organizations

Roles and Responsibilities

• Project Leadership and management of multiple CMO/CRO activities and manufacturing operations for projects under development (from API starting material through Drug Product), including Technology Transfer.
• Ensure Clinical and Pre-Clinical manufacturing requirements are met ranging from supply to regulatory assistance, oversight, and audit readiness
• Develop and participate in the process for selecting appropriate CRO/CMO and monitoring performance
• Implementation of robust manufacturing process/systems, with associated leadership of in house project teams, and timeline management at our contract manufacturing organizations.
• Implementation of the Unity Quality System within Manufacturing including process monitoring, process controls, KPIs, and Quality Risk Management
• Report writing including product life cycle reports, investigation reports, change controls, protocols, development reports, regulatory filings
• Batch Record Analysis/review, SOP preparation and review, data collection/trending, quality and supply agreement evaluation, and analysis of CMO/CRO procedures
• Manage data and reports, agreements, batch records, procedures w/GMP Starting Material and API, and DP manufactures
• Planning and tracking of activities and spend with
• Managing the work of scientist at CRP/CMO organizations thru data analysis, knowledge of internal SOPs, and understanding Unity’s short-term/long-term goals.
• Lead sub-groups, serve as Unity Manufacturing representative, and collaborate with other departmental functions w/in Unity
• Person in Plant as needed
• Other Responsibilities as needed and assigned by supervisor

Requirements

• MS/PhD with 10+ years in small molecule pharmaceutical manufacturing, development, and outsourcing. A background in pharmaceutical sciences, chemical engineering, and/or quality control preferred.
• Proven track record of successful project management, cross functional collaboration, especially with foreign based CRO/CMO projects where daily oversight, budget and timelines were achieved.
• Strong PM, verbal communication and written communication skills
• Knowledgeable in current GMP/GLP and regulatory requirements (US, Canada, EU)
• Experience with lifecycle product management
• Extremely motivated individual able to work with other Operations areas (Quality, Supply Chain, Regulatory CMC) involved in drug development and manufacturing to solve complex problems
• Be a team player in a dynamic fast paced virtual biotechnology environment where collaboration and partnership is the norm
• Travel Requirement 10-30%

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Chief Executive Officer
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Senior Manager/Associate Director of Pharmaceutical Development

Unity Biotechnology is seeking an exceptional and highly motivated individual to join the Pharmaceutical Development group. Reporting to the VP of Technical Operations, the individual will lead pharmaceutical activities across a dynamic development and discovery space. The successful candidate will be flexible, have strong leadership skills, and have experience in pharmaceutical development beyond solid oral dosage.

Responsibilities

• Develop phase appropriate small molecule sterile liquid, suspension, and lyophilized formulations for parental and pulmonary clinical administration.
• Develop small molecule topical formulations for clinical administration.
• Perform pre-formulations experiments in-house and work closely with Unity’s internal discovery organization to develop GLP appropriate formulations.
• Working closely with Unity’s head of manufacturing, help to evaluate and select pharmaceutical development and manufacturing CROs and CMOs. Monitor and troubleshoot on-going manufacturing and development activities.
• Review master batch records, stability, and development reports.
• Act as an SME on multidisciplinary project teams.
• Authorship of regulatory documents and technical reports.

• Development of immediate release and controlled release formulations.
• Alignment and understanding of phase appropriate analytical and quality requirements for GMP drug products.

Qualifications

• PhD in pharmaceutical sciences, chemical engineering, or chemistry with minimum of 8 years of pharmaceutical industry.
• Successful track record of developing clinical formulations. Commercial experience not necessary but desirable.
• Experience and first-hand use of common pharmaceutical and analytical equipment.
• Extensive understand of GMPs, GLPs, and industry best practices.
• Ability to work collaboratively on multiple projects and with numerous stakeholders in a fast-paced environment.
• Familiar with the overall drug development process outside of pharmaceutical development.
• Up to 25% travel.

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Chief Executive Officer
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Chief Executive Officer
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[av_heading heading=’BRIS.101 – Clinical Project Manager’ tag=’h1′ style=’blockquote modern-quote modern-centered’ size=’32’ subheading_active=” subheading_size=’15’ padding=’10’ color=’custom-color-heading’ custom_font=’#6a8494′]
Chief Executive Officer
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UNITY Biotechnology is a nascent integrated biopharmaceutical company discovering and developing medicines to treat chronic diseases associated with aging. We are located in the San Francisco Bay Area and are seeking to hire a Clinical Project Manager (CPM). The CPM will be responsible for providing clinical project support for a given Clinical Program within UNITY’s Senolytic Drug Development Program. In addition, the successful candidate will collaborate with the Head of Clinical Operations and Chief Medical Officer to facilitate attainment of the translational research goals of the Clinical Development Plan. The position provides vital support for clinical systems infrastructure and clinical administrative and organizational needs. In addition, the CPM will ensure that clinical implementation methodology is conducted in accordance with Good Clinical Practice, applicable rules and regulations, ethical standards, and UNITY’s Standard Operating Procedures and guidelines. The CPM will provide programmatic support that may include but not be limited to the following activity:

• Developing clinical plans, timelines and budgets
• Managing all operational aspects of trial implementation, including ensuring compliance with GCP, SOPs, and Regulatory requirements
• Developing Clinical Protocols and associated documentation, such as Informed Consent Forms (ICFs), eCRFs, Data Capture Tools (Patient Reported Outcomes), and technical study manuals
• Managing regulatory and core clinical documentation (Trial Master File)
• Overseeing Quality Management as it pertains to a given trial or program
• Managing clinical strategic outsourcing, including vendor selection and oversight, and development of the vendor management plan
• Managing Central Laboratories and working with the Translational Research team to support the Biomarker Plan.

Requirements:

• Bachelor’s degree (BS/BA/BScN or higher) in a scientific field
• 5+ years of clinical study management experience in the biopharmaceutical domain and at least three years of clinical study lead or project management experience. Total 8-10 years of relevant experience preferred.
• At least two years of experience managing outsourced studies. Direct site monitoring and experience of managing audits or undertaking inspection preparedness preferred
• Sound computer skills: proficient in Excel, Word, and EDC systems, and able to learn new systems and train others. Highly competent in an electronic environment (prior experience with eTMF systems highly advantageous)
• Strong understanding of clinical trial domain and documentation management.
• Understanding of GCLP and the conduct of clinical trial assays is advantageous
• Strong understanding of laboratory matters as they pertain to clinical trials, and an ability to track and aggregate information from disparate systems (laboratory portals, EDC systems, Vendor tracking tools)
• Ability to work with a high degree of initiative and independence while exercising appropriate judgement
• Thorough knowledge  of  ICH/GCP guidelines, FDA requirements  for  INDs, NDAs, and drug approval process
• An understanding of Quality Management and the Quality Cycle as it pertains to the clinical trial domain. A strong understanding of the lifecycle of Clinical Quality
• Documentation (SOPs) and ability to manage in a document control environment
• Meticulous attention to detail and ability to collaborate in development of clinical plans and execute to those plans in a timely manner
• Very strong organizational, communication (oral and written), and interpersonal skills
• Advanced problem-solving skills and ability to think creatively and apply innovative solutions to achieve the desired outcome
• Multi-tasking skills and ability to manage multiple competing tasks, tracking multiple deadlines and competing activitiesPlease send resume and cover letter to careers@unitybiotechnology.com

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[av_heading heading=’BRIS.102 – Scientist or Senior Scientist, in vitro Pharmacology’ tag=’h1′ style=’blockquote modern-quote modern-centered’ size=’32’ subheading_active=” subheading_size=’15’ padding=’10’ color=’custom-color-heading’ custom_font=’#6a8494′]
Chief Executive Officer
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Unity Biotechnology is a nascent integrated biopharmaceutical company discovering and developing medicines to treat chronic diseases associated with aging. We are located in the San Francisco Bay Area and are seeking to hire a Scientist or Senior Scientist in tissue evaluation and in vitro modeling. This position will afford the successful individual an opportunity to create clinical candidates for an emerging and exciting biology and to translate that into a pipeline of differentiated medicines. The successful candidate should be a highly innovative and creative scientist who has expertise evaluating diseased tissue explants and developing in vitro models of diseases to test novel molecules designed to selectively eliminate senescent cells.

The successful candidate will be both a strong lab-based individual contributor and a team player who synergizes with other scientists. The Scientist in this role will develop in vitro models to characterize candidate molecules in diseased human tissues. The duties of the job include experimental design and execution, analysis and interpretation of data, and presentation (verbal/written) of findings to the Discovery team. Depending on experience, the candidate will lead a small group. The candidate will have an important role in the generation of key datasets that are critical for the declaration of development candidates.

Requirements:

• Ph.D. degree with 2-4 years of scientific experience in the biopharmaceutical industry
• Degree in Cellular Biology, Pharmacology or a related field is essential
• Evidence of independent scientific ability (e.g., post-doctoral training) and a track record of scientific accomplishments through publications, patents, and invited presentations
• Direct experience across a range of different therapeutic areas and target tissues (e.g., liver, eye, lungs, and/or kidneys) is preferable
• A background in aging, immunology, oncology, or assessment of cellular senescence in tissue is an asset
• Experience working with human tissues (dissection/cell dissociation, explant cultures) and various primary cell types is essential; experience with quantitative measures in tissue explants (e.g., potency, target engagement) is desirable
• Experience with flow cytometry, immunohistochemistry and multiplexed antibody-based detection methods is an advantage
• Hands-on proficiency with laboratory automation and microplate-based assay formats is highly desirable
• Ability to manage complexity in a highly matrixed work environment
• Experience and strong capabilities in managing, developing, and mentoring scientists and research associates
• Creativity and the ability to lead and/or work within an interdisciplinary team to in order to achieve technical and corporate milestones
• Exceptional communication, critical thinking, and problem solving skills

Please send a resume and cover letter to careers@unitybiotechnology.com.
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[av_heading heading=’BRIS.103 – Research Associate, in vitro Pharmacology’ tag=’h1′ style=’blockquote modern-quote modern-centered’ size=’32’ subheading_active=” subheading_size=’15’ padding=’10’ color=’custom-color-heading’ custom_font=’#6a8494′]
Chief Executive Officer
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Unity Biotechnology is a nascent integrated biopharmaceutical company discovering and developing medicines to treat chronic diseases associated with aging. We are located in the San Francisco Bay Area and are seeking to hire a Research Associate or Senior Research Associate in tissue evaluation and in vitro modeling. This position will afford the successful individual an opportunity to create clinical candidates for an emerging and exciting biology and to translate that into a pipeline of differentiated medicines. The successful candidate should be a highly innovative and creative biologist who has hands‑on experience with in vitro cellular- or tissue-based models for the identification and optimization of novel molecules.

The successful candidate will be both a strong lab-based individual contributor and a team player who synergizes with other scientists. The Research Associate in this role will develop in vitro models to characterize candidate molecules in diseased human tissues. The duties of the job include experimental design and execution, analysis and interpretation of data, and presentation (verbal/written) of findings to the Discovery team. The candidate will have an important role in the generation of key datasets that are critical for the declaration of development candidates.

Requirements:

• Bachelor’s degree with 2-4 years of scientific experience in the biopharmaceutical industry or a Master’s degree with 1-2 years of experience
• Degree in Cellular Biology, Pharmacology or a related field is essential
• Experience conducting quantitative human cell-based assays is required; experience with human tissues (dissection/cell dissociation, explant cultures) and various primary cell types is preferable
• Experience with flow cytometry, immunohistochemistry and multiplexed antibody-based detection methods is an advantage
• Hands-on proficiency with laboratory automation and microplate-based assay formats is highly desirable
• Creativity and the ability to work within an interdisciplinary team to in order to achieve technical and corporate milestones
• Exceptional communication, critical thinking, and problem solving skills

Please send a resume and cover letter to careers@unitybiotechnology.com.
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[av_heading heading=’BRIS.106 – Research Associate or Senior Research Associate, in vivo Pharmacology’ tag=’h1′ style=’blockquote modern-quote modern-centered’ size=’32’ subheading_active=” subheading_size=’15’ padding=’10’ color=’custom-color-heading’ custom_font=’#6a8494′]
Chief Executive Officer
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We are seeking to hire a Research Associate or Senior Research Associate in vivo pharmacology. This position will afford the successful individual an opportunity to create clinical candidates for an emerging and exciting biology and to translate that into a pipeline of differentiated medicines. The successful candidate should be highly innovative and creative and have experience in conducting in vivo models of disease to evaluate therapeutic interventions. The successful candidate will be both a strong individual contributor and a team player with responsibilities that are primarily lab-based. The research associate in this role will evaluate the efficacy of compounds in in vivo animal models. The duties of the job include experimental design and execution, analysis and interpretation of data, and presentation (verbal/written) of findings to the Discovery team. The candidate will have an important role in the generation of key datasets that are critical for the declaration of development candidates. The successful applicant will also contribute to keeping the lab in compliance with animal services requirements.

Requirements:

• Master’s degree with 2 years of scientific experience or Bachelor’s degree with 2 years of scientific experience in the biopharmaceutical industry
• Degree in cellular biology or a related field is desirable
• Technical expertise in handling rats and mice
• Strong experience and interest in developing new animals models of human disease
• Experience with immunohistochemistry, PCR, quantitative PCR, SDS-PAGE, western blotting, and immunostaining
• Knowledge on flow cytometry is desirable
• Creativity and the ability to work within an interdisciplinary team in order to achieve technical and corporate milestones
• Communication (written, verbal, data recording) and organizational skills are highly recommended

Please send a resume and cover letter to careers@unitybiotechnology.com.
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[av_heading tag=’h1′ padding=’10’ heading=’Research Associate or Senior Research Associate, Molecular and Cellular Biology’ color=’custom-color-heading’ style=’blockquote modern-quote modern-centered’ custom_font=’#6a8494′ size=’32’ subheading_active=” subheading_size=’15’ custom_class=”]
Chief Executive Officer
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Unity Biotechnology is a growing biopharmaceutical company located just South of San Francisco in Brisbane, California. We are developing medicines to treat chronic diseases associated with aging and conducting cutting edge research on cellular senescence and its implications in human health and longevity.

We are looking for a Research Associate to join the Senescence Biology Group which bridges basic and translational research to discover and move candidate therapeutics through the pipeline for different medicines and clinical indications. The successful candidate should be highly motivated and have experience with mammalian cell culture, cell-based models of disease, and running/developing screening assays.

The successful candidate will be a strong member of a small team with both individual and group responsibilities. Duties will be primarily lab based evaluating compounds’ efficacy in cell based assays and in vitro models of disease. Duties will include experimental design and execution, including data analysis and communication (both written and verbal) to the Senescence Biology and greater Discovery groups of the company. Meticulous record keeping is a must, and the individual should master their tasks and understand how their data fit into the larger goals and development of clinical candidates. We are looking for the intelligent, friendly, hard-working individual who can contribute to and grow with the programs and company.

Requirements:

• Master’s degree in relevant field or bachelor’s degree with 2-5 years scientific or biopharmaceutical industry experience.
• Degree in cellular biology or related field (molecular or chemical biology; biochemistry; biophysics; genetics etc.)
• Direct experience with mammalian tissue culture and cell based assays with a preference for work conducted with primary cells.
• Experience with use and evaluation of small molecules and/or shRNA in cell culture
• Critical thinking, communication, and problem solving skills
• Good work ethic and willingness to work in a group to support and achieve technical and corporate milestones
• Experience with most of the following techniques: SDS-PAGE, western blotting, PCR, qPCR, shRNA, fluorescence microscopy
• Experience with liquid handling devices and laboratory automation is highly desired, but not required

Please send a resume and cover letter to careers@unitybiotechnology.com
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[av_heading tag=’h1′ padding=’10’ heading=’Director, Medicinal Chemistry’ color=’custom-color-heading’ style=’blockquote modern-quote modern-centered’ custom_font=’#6a8494′ size=’32’ subheading_active=” subheading_size=’15’ custom_class=”]
Chief Executive Officer
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We are seeking to hire a Director of Medicinal Chemistry. This leadership position will afford the successful individual an opportunity to create clinical candidates for an emerging and exciting biology and to translate that into a pipeline of differentiated medicines. The successful candidate should be a highly innovative and creative scientific leader who can develop novel small molecules designed to selectively eliminate senescent cells in diseases associated with aging.

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