We are seeking a scientifically accomplished and visionary leader to serve as Senior Director, Analytical & Formulation Sciences (AFS). This role is responsible for directing and overseeing formulation and analytical activities across processes, instrumentation, and laboratory operations, ensuring the delivery of high-quality biologics development from early-stage through commercialization. Ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels.
The Senior Director will lead a multidisciplinary team of scientists and technical experts while driving innovation, operational excellence, and client success in a dynamic CDMO environment.
Key Responsibilities
Full responsibility for the direction of all assigned analytical and formulation activities.
Execute research and development requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by the VP, Analytical Formulation and Sciences.
Evaluate, develop and implement new formulation technologies leading to process improvements and efficiency of operation.
In cooperation with Quality Assurance, Finance and Commercial Development, evaluate feasibility/ assess risk of implementation of project development processes.
Specifically review product/process development and manufacturing operations for adaptability with existing facility configuration. Develop preliminary schedules along with material/personnel/equipment requirements to allow accurate contract pricing and appropriate performance guarantees.
Develop and maintain budgets, manpower and capital requirements for formulation/analytical areas. Develop and monitor performance criteria so as to allow measurement and continuous improvement of efficiency and quality, thereby ensuring meeting of committed targets of on-time and error-free performance.
In cooperation with customer representatives, identify process improvements in all laboratory areas.
Provide facility expansion support as needed by Facilities Engineering to meet expansion timeline and cost requirements.
Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
Strategic & Operational Leadership
Provide full leadership and direction of all analytical and formulation activities across the AFS organization
Establish and execute strategy for analytical lifecycle management and product development from early phase through commercialization
Ensure effective use of materials, equipment, and personnel to meet productivity, quality, and capacity objectives
Scientific & Technical Excellence
Oversee analytical characterization and formulation development for complex biologics (e.g., monoclonal antibodies, vaccines, viral vectors, cytokines
Ensure delivery of high-quality, interpretable data using advanced analytical instrumentation and techniques
Evaluate and implement new formulation technologies to enhance process robustness and efficiency.
Cross-Functional & Client Engagement
Partner with Quality, Process Development, Regulatory, Finance, and Commercial teams to ensure successful program execution and risk mitigation
Collaborate with clients to define scope, deliver rapid-turnaround testing, and identify process improvements
Assess feasibility of development programs and align with facility capabilities, timelines, and cost structures
Operational & Financial Management
Develop and manage budgets, headcount planning, and capital investment strategies for AFS labs
Define and track performance metrics to ensure on-time, error-free delivery and continuous improvement
Support facility expansion and infrastructure planning as People Leadership
Lead, mentor, and develop a high-performing scientific organization
Build a culture of innovation, accountability, quality, and customer focus
Attract, retain, and grow top scientific and technical talent
Requirements:
Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 17 years of technical management experience; or a Master’s degree with 15 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent) and 10+ years related experience and/or training preferred. Additionally, at least 5 years of experience serving in a relevant managerial capacity required.
Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essential tasks as assigned.
Also requires a demonstrated track record in the following key areas:
Attainment of aggressive growth and profit objectives
Strong orientation for Quality and Customer Service
Demonstrated level of respect for individuals
Demonstrated contribution to science in appropriate area
High level of integrity and personal responsibility
Record of innovation
Strong collaboration and team building skills
Proven leadership in analytical development within a CDMO or biopharma setting
Deep expertise in particle and biophysical characterization techniques and regulatory expectations
Strong communication, project management, and client engagement skills
Extensive experience characterizing cytokines, interferons, growth factors, monoclonal antibodies and conjugates, vaccines, viral vectors, and biosimilars
Salary Range: $189,000-$263,000
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Skills Required
- Relevant scientific degree with experience (BS +17 years, MS +15 years, or PhD +10 years)
- Minimum 5 years in a managerial capacity leading scientific teams
- Knowledge of GMPs and biotechnology-derived product regulations
- Proven leadership in analytical development within a CDMO or biopharma setting
- Deep expertise in particle and biophysical characterization techniques and regulatory expectations
- Extensive experience characterizing cytokines, interferons, growth factors, mAbs, conjugates, vaccines, viral vectors, and biosimilars
- Experience with formulation development and implementing new formulation technologies
- Strong communication, project management, client engagement, and cross-functional collaboration skills
- Experience developing and managing budgets, headcount planning, and capital requirements
KBI Biopharma Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about KBI Biopharma and has not been reviewed or approved by KBI Biopharma.
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Healthcare Strength — Health coverage includes medical, dental, and vision with HSA/FSA options, alongside life and disability insurance. Employer-verified listings indicate solid foundational coverage across sites.
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Leave & Time Off Breadth — PTO and paid holidays are provided, with flexible or “unlimited” PTO available in some salaried roles and standard accrual with limited rollover elsewhere. This breadth supports time away options across job families.
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Parental & Family Support — Parental leave is available, with indications of 12 weeks for U.S. employees in recent materials. Maternity and paternity leave are included as part of the package.
KBI Biopharma Insights
What We Do
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. KBI is proud to be a JSR Life Sciences Company.
