Manager, Process Development

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Job description

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Manager, of Development Services will owns the development lifecycle and project plan for multiple Viral Vector projects. Development Manager will supervise daily routine lab duties to ensure that client requirements are met and company profits are considered. Will maintain the laboratory within the requirements of Lonza standard regulations, while maintaining appropriate documentation for developmental projects. Manager will be a leader internally and have responsibilities to own with Clients.

Key responsibilities:

* Defines the scope of work and develops experimental design with assistance from the team. Maintains scheduling of products/projects. Supervises daily lab duties. Delegates projects. Resolves problems. Manages upkeep of departmental equipment.

* Manages resources for relevant client projects and reviews and updates for Viral Vector Development resource planning tool for relevant projects and direct reports. Ensure that process development resources are effectively deployed to maximize team output, ensure people development with a strong focus on cross-training.

* Determines feasibility of labor estimates, and/or costs of production for each custom request received, and for PD projects as requested.

* Attends and participates in department and client meetings. Participates in Customer Audits. Prepares methods/draft batch records for PD projects transferring to VV. Prepares monthly management reports.

* Effectively identify and escalate process risks, prepare project progress summaries for management review and develop and manage project timelines. Prepares and reviews presentations, protocols, and PD reports.

* Develops and implements departmental SOP's, DMR's, labels, PQA documents, written materials. Understand at-scale cGMP manufacturing process and constraints to develop principles for process development in the lab and successful transfer.

* Work closely with Lonza's global network to share knowledge and implement best practices and procedures.

* Hires, trains and conducts evaluations of department personnel. Aggressively work towards maintaining a positive and collaborative work environment between groups and across departments.

* Work closely and effectively communicates with Project Management, MSAT, and manufacturing to ensure that process development activities are standardized allowing for timely and successful transfer of processes into clinical manufacturing.

Key requirements:

* PhD Degree in Life Sciences or related discipline plus several years of related laboratory experience, including few years of supervisory experience. (Years of experience may substitute for education in some instances).

* Knowledge of biology, bioengineering, chemistry, statistical analysis, technical writing.

* Knowledge of basic specialized laboratory equipment including laminar flow hoods, centrifuges, cell culture systems, incubators, WAVE and STRS

* Knowledge of Cell Biology, cell culture, bioreactors.

* Strong knowledge of cGMP, aseptic techniques and auditing techniques.

* Cell culture experience

* Time Management skills; facilitation skills; delegation skills; computer software skills (specifically databases, Microsoft Office, Adobe Photoshop); organization, record keeping and planning skills; training skills; ability to manage multiple projects; time management skills.

* Excellent oral and written communication skills, across all levels of the organization and ability to authoritatively discuss technical issues with internal and customer experts. Prior experience in an external customer facing role is highly desirable.

* Comfortable handling rapidly changing priorities common to a contract manufacturing environment.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R37268

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