Careers

Position Description

​The Senior Engineer, Manufacturing Process Development position will play a crucial role in developing, optimizing, and scaling up manufacturing processes for our novel technology. This position requires a blend of scientific expertise, technical skills, and leadership abilities to drive manufacturing process development and improvements and ensure efficient, high-quality production practices are developed to support product development partnerships.

​

Responsibilities/Essential Functions:

• Guide the development and optimization of manufacturing processes from small lab-scale to full GxP production at CDMO for clinical use.

• Design and execute experiments to identify and improve process efficiency, yield, and product quality.

• Analyze complex data sets and provide actionable insights to guide process development decisions.

• Guide preparation and completion of development reports to summarize manufacturing development activities to:

  • Guide tech transfer of Lindy technology to CDMO partners for scale up.

  • Support development of Lindy Intellectual Property to assist company growth.

• Collaborate closely with cross-functional teams, including R&D, Formulation, Quality Control, and Analytical as required.

• Author and review technical protocols and reports, batch records, and standard operating procedures (SOPs) as necessary.

• Troubleshoot process development issues and implement effective solutions.

• Mentor junior scientists and technicians in process development techniques.

• Ensure compliance with company quality standards.

​​

Requirements:

Minimum Required Education and/or Experience

• Educational training in Material Sciences, Chemical Engineering, Mechanical Engineering, Biochemistry, or related sciences field (degree commensurate with experience).

• Minimum of 5 years of experience in biopharmaceutical process development.

• Prior supervisory and project management experience leading technical operations development teams strongly preferred.

• Strong knowledge of manufacturing and techniques.

• Familiarity with quality by design (QbD) principles and process analytical technology (PAT):

• Demonstrated expertise in design of experiments (DoE) and leading application of DOE in technical operations to support development strategies.

• Understanding of analytical techniques and methodologies used for establishing quality control release specifications.

• Experience with scale-up and tech transfer of manufacturing processes and interaction with CDMOs strongly preferred.

• Excellent analytical and problem-solving skills and strong communication and interpersonal abilities are essential.

• Strong computer literacy in relevant programs and ability to identify and summarize complex technical issues in written form is essential.

• Ability to work effectively in a fast-paced, collaborative startup environment.

• Experience with regulatory submissions and interactions with health authorities desired.

​

Supervisory Responsibilities:  The Senior Engineer will manage team members in Manufacturing Process Development as needed, including mentoring junior Engineers.  

​

Travel:  Occasional travel to CDMO may be required.

​

Physical Demands:

• This job primarily operates in both a professional office setting and a research laboratory setting.

• Frequent use of standard office equipment, such as computers, phones, copiers, and scanners is required.

• Must be able to bend, lift, and carry up to 25 pounds.

​

Affirmative Action/EEO statement: 

Lindy Biosciences is an equal employment opportunity employer and do not discriminate against any person because of race, color, creed, religion, national origin, political affiliation, sex, gender identity or expression, sexual orientation, age, disability, genetic information, or other reasons prohibited by law (referred to as "protected status"). This nondiscrimination and opportunity policy extends to all employment actions such as promotions, compensation, benefits and termination of employment.

 

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

How to Apply

​Please send a resume and cover letter to careers@lindybio.com