Director Process Development Jobs

A minimum of 10 years of progressive experience in both upstream and downstream bioprocess development within the biopharmaceutical industry.

Comprehensive understanding of regulatory compliance and quality requirements in biologics manufacturing.

The VP – Process Development has the following qualifications:

Spearhead the integration of cutting-edge downstream methodologies and technologies, driving the adoption of novel approaches to enhance productivity and streamline processes.

Lead initiatives focused on optimizing downstream processes, maximizing yield, and minimizing costs while maintaining the highest product quality.

Act as a visionary for cell line development, media development, cell culture, bioreactor/fermenter, scale-up, purification, separation, filtration, TFF, UF/DF, AKTA.

* 8+ years of Biotechnology industry experience leading upstream mammalian cell culture process development.

* Experience leading cross-functional, multi-national teams including tech transfer teams.

* Competitive base salary, target bonus, retirement allowance and excellent medical benefits.

Preferred Candidate Background and Expertise:

* MS or Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, Biology or related Life Sciences field.

* Ability to build and maintain strong, positive relationships with customers.

5+ years managerial experience in drug product development operations;

Provide oversight and innovative leadership for formulation development, process design & development, process scale-up and transfer, and optimization of patient experience;

Thorough knowledge of freezing and thawing of bulk protein solutions and cell therapy products, and freeze-drying processes for protein products;

Strong leadership, interpersonal, communication, and team building skills;

Ability to multi-task and adapt to changing business requirement in a dynamic, matrix environment. Understands business on a global scale;

Prior experience with IND/IMPD submissions for biologics

Strong project management and organizational skills and ability to prioritize and multitask.

Experience with mammalian cell culture and preferred experience with PSCs.

Proven experience in molecular biology laboratory techniques.

Effective communication with excellent organization and interpersonal skills.

Experience in gene expression analysis and next generation sequencing.

Knowledge of R, Python, Bionano instrument and FlowJo.

Drive development and implementation of new systems to improve project execution and data management

Experience and understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics

Develop and manage department budget

Experience supporting regulatory filings (e.g., IND, BLA, MAA) and supporting product-related inspections for US and foreign regulatory agencies

Experience developing, implementing and executing strategic plans and objectives for organizations and departments

Provide leadership and direction to the Process Development organization, a department of 60+ scientists and engineers

Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.

Excellent math, documentation, communication and operational troubleshooting skills. General proficiency with tools, systems, and procedures required to accomplish the job.

Proven knowledge of oligonucleotide synthesis, purification, ultrafiltration, conjugation, and lyophilization is helpful.

Essential duties and responsibilities include but are not limited to:

The salary range for this position may differ based on your actual work location

Required Qualifications – Education, Skills & Experience

Preferred Qualifications – Education, Skills & Experience

Interpersonal skills: Persuades managers and leaders to act and/or negotiates with external partners/vendors/customers.

Business Acumen: Applies knowledge of key business drivers and the factors that maximize department performance.

Leadership: Manages multiple related teams, sets departmental priorities, and allocates resources to align with business objectives and annual plan.

Provides guidance on the interpretation of operating unit data, monitors catalyst performance, recommends unit operating guidelines, and estimates remaining catalyst life.

Deep knowledge of process optimization and development techniques, including familiarity with current industry practices and regulatory requirements.

Extensive experience (at least 10 years) in process development within the biopharmaceutical industry.

Strong scientific leadership skills, demonstrated through publications, presentations, and collaborations within the field.

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.

Bachelors degree in a scientific discipline, advanced degree preferred

Proven track record of successfully leading and managing teams, with the ability to inspire and motivate individuals to achieve goals.

Coordinate and support change management and training on medical writing processes and templates for all internal and external stakeholders.

Provide centralized management for all process-related Medical Writing initiatives.

Expert knowledge of global regulatory affairs, particularly the regulatory documentation requirements and mechanisms of the United States and Europe.

Issue resolution skills, being able to manage cross-functional teams through complex processes given clear direction.

Leadership skills and presentation skills to influence, negotiate, and collaborate with teams for any medical writing process and template initiatives.

Strong negotiation and conflict resolution skills.

Manage complex calendar for VP of Process Development

Manage and facilitate agendas for weekly meetings. Responsible for tracking action items within

Bachelor’s degree (or equivalent experience) OR

Associate Degree and 2+ years of administrative experience supporting an Executive Director or VP level OR

High School Degree and 3+ years of administrative experience supporting an Executive Director or VP level

Experience working in a team environment with other administrative assistants

Flexibility and a willingness to expand skill set and responsibilities is a must.

Manages upstream functional resources that support multiple cross-functional teams.

Ability to think critically, and demonstrated troubleshooting and problem-solving skills.

Excellent interpersonal, communication, and presentation skills are required.

Experience with antibody and antibody-like proteins is required; experience with other modalities preferred.

Experience with technology development/implementation projects both functionally and cross-functionally is preferred.

3-5 years of manufacturing experience in the food industry

Experience with manufacturing processing equipment and/or with verification/ validation of equipment and thermal processing would be an advantage.

Strong Microsoft Office skills (particularly Excel)

Knowledge of ERP systems (preferably Ross)

Collaborate with the cross-functional team to develop and commercialize new products, highlighting any risks from a manufacturing and quality aspect.

Transition R&D recipes to scaled-up, factory-ready recipes including step-by-step preparation and cooking procedures.

Strong communication and organization skills are a must.

Sr. Scientists is expected to manage projects and people.

This candidate must be experienced in the development and optimization of cell culture processes for the production of cell therapy products.

Experience with variety of cell culture systems and optimization of cell expansion and differentiation process.

Experience with development of bioreactor protocols and scale up studies for mammalian cells or stem cells is highly desirable

Design and review of experiments of cell process optimization, Bioreactor scale up and cryopreservation, trouble shoot the problems.

5+ years managerial experience in drug product development operations;

Provide oversight and innovative leadership for formulation development, process design & development, process scale-up and transfer, and optimization of patient experience;

Thorough knowledge of freezing and thawing of bulk protein solutions and cell therapy products, and freeze-drying processes for protein products;

Strong leadership, interpersonal, communication, and team building skills;

Ability to multi-task and adapt to changing business requirement in a dynamic, matrix environment. Understands business on a global scale;

Prior experience with IND/IMPD submissions for biologics

Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Experience leveraging statistical Design of Experiments (DoE) strategies

Progressive years of industry experience in cell therapy drug product process development and/or manufacturing, including formulation, filling, finish, and cryopreservation

Proven ability to build, manage and mentor a team of talented scientists and engineers

Prior experience working on a clinical or commercial cell therapy manufacturing process

Extensive hands-on experience in formulation development and designing and scaling fill/finish and cryopreservation processes, such as aseptic filling and controlled-rate freezing

Author high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings

Experience working in a GMP environment and familiarity with quality requirements, USP, and FDA regulations

Excellent data analysis skills and experience with a variety of scientific software applications

Manage tech transfer and process development activities to enable regulatory filing

Performing and supporting in the execution of verification, validation, and performance qualification

Excellent organizational and communications skills and strong ability to lead and work with individuals across all levels in the organization

Excellent data analysis skills and experience with a variety of scientific software applications.

Build and sustain strong relationships with internal and external stakeholders to meet Business requirements.

Experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+, etc..).

Experience in developing & implementing cell therapy manufacturing processes and systems.

Experience with manufacturing genetically modified cell therapy products, ideally both in industry and academia.

Experience in tech transfer and process characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment.