Senior Director, Analytical & Formulation Sciences

Job Summary

We areseekinga scientifically accomplished and visionary leader to serve asSenior Director Analytical & Formulation Sciences (AFS). This roleis responsible fordirecting and overseeing formulation and analytical activities across processes instrumentation and laboratory operations ensuring the delivery of high-quality biologics development fromearly-stagethrough commercialization.Ensures the effective use of materialequipmentand personnel while developing products and processes athigh qualitylevels.

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 capacityobjectivesas set forth by the VP Analytical Formulation and Sciences.

• Evaluatedevelopand 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 allowaccuratecontract pricing andappropriate performanceguarantees.

• Develop andmaintainbudgetsmanpowerand capital requirements for formulation/analytical areas. Develop andmonitorperformance criteriaso as toallow 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 representativesidentifyprocess 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;guidethe professionalgrowth 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 andidentifyprocess 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

• Attractretain 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 aMastersdegree 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.

Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essentialtasks asassigned.

• Also requires a demonstratedtrack recordin 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 inappropriate area

• High levelof integrity and personal responsibility

• Record of innovation

• Strong collaboration and team building skills

• Proven leadership in analytical development within a CDMO or biopharma setting

• Deepexpertisein 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: $189000-$263000