Biochemical Process Engineer

Position Summary

The Biochemical Process Engineer is responsible for the design and implementation of chemical processes, instrumentation, and equipment to bring manufacturing efforts to scale with maximum efficiency and productivity.

Primary Duties

The Biochemical Process Engineer is responsible for the industrialization of chemical processes, instrumentation, and equipment to ensure effectiveness in process engineering and design and bring manufacturing/production efforts to scale with maximum efficiency and productivity. Performs trials, tests, and/or experiments to support Engineering, manufacturing, and/or R&D activities. The Biochemical Process Engineer works with a cross-functional team and external vendors to develop new process formulas and technologies to achieve cost-effectiveness and improve product quality for existing and future products. Establishes operating equipment specifications and improves manufacturing techniques. Familiar with a variety of the field’s concepts, practices, and procedures, including Chemistry, Biochemistry, Enzymology, PCR, process automation, and manufacturing scale-up. Will receive general instructions on routine work and detailed instructions on new assignments. They will also support existing project needs for freeze-drying, buffer/master mix formulations, and oligonucleotide manufacturing as part of the overall manufacturing process.  

 
Principle Job Duties and Responsibilities 

1. Perform all work in compliance with company policy and within the guidelines of the Quality System.
2. Expected to understand and contribute to the design and development of complex manufacturing processes. These include but are not limited to chemistry formulations, freeze drying, and oligonucleotide manufacturing processes. A thorough and up-to-date knowledge of the current processes is critical to the success of this position.
3. Establish new equipment and processes.
   1. Communicate with vendors and suppliers to identify new technologies for future implementation and to optimize product performance.
   2. Develop proof of principle concepts with potential vendors and suppliers
   3. Design equipment configuration to suit the product range and the process technologies.
   4. Development of new instrumentation, software or processes, manufacturing support, and training functions.
   5. Responsible for the development of processes and subsequent implementation and sustainment in manufacturing.
   6. Onboard new equipment and establish documentation for manufacturing processes.
4. New technologies
   1. Maintain broad knowledge of state–of–the–art principles and theories necessary to identify previously unknown process variables and to implement best practices and corrective actions.
   2. Communicate to leadership teams on chemical processing techniques and trends.
   3. Demonstrates technical proficiency, scientific creativity, collaboration with others, and independent thought.
   4. Use professional concepts to contribute to the development of company processes and principles, and to achieve objectives in creative and effective ways.
   5. Generate technical documentation, including WIDs, technical reviews, studies, and executive summaries. Ensure proper documentation for regulatory compliance.
   6. Develop process inputs and provide outputs for downstream equipment and processes.
   7. Perform principal duties and responsibilities in a clean room environment. 

Supplemental Data

• This position will report to the Director of Reagents Industrialization. There may be future needs to create direct reports to allow additional resources, in which this position would supervise and mentor these positions.
• The franchise is a multi-site, 24/7 operation with more than $1B in annual revenue and significant growth across multiple regions expected in the next five years. 

Qualifications

Training and Education

Required: Bachelor’s degree in Chemical Engineering or a related field. 

Preferred: Master’s degree or Ph.D. in a Scientific field (i.e. Biochemistry, Chemistry, or related) or Biological, Chemical, or Process Engineering.

Experience

• No additional experience is required for individuals with a Ph.D., although preference will be given to individuals with related industry experience.
• For a Graduate degree, work industry experience can be substituted for 5 years of education.
• For individuals with a Bachelor’s degree, 10+ years of directly related experience is required.
• Previous experience with the following is preferred:
• Experience in an FDA-regulated industry
• Process Engineering
• Freeze Drying
• Analytical Chemistry
• PCR
• Chemical formulation
• Oligo manufacturing and/or enzymology
• Manufacturing automation
• Manufacturing scale up 

Knowledge, Skills, and Abilities

Skills:

• Ability to successfully collaborate with internal stakeholders and teams.
• Solid communication skills, both written and verbal
• Ability to manage and articulate complex processes.
• Practical time management skills and the capability to prioritize competing tasks within timelines.
• Problem-solving and propensity for identifying creative and effective solutions.
• Demonstrated proficiency in successfully building and maintaining relationships as a member of a technically diverse team. 

Working Conditions and Physical Requirements

Check if applicable.

• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.
• Domestic travel required    __10__ % of time.
• International travel required   __5__ % of time.
• Must be able to perform job duties while wearing a Purifying Air Personal Respirator (PAPR) 

Supervisory Responsibilities

Direct supervision (approximate) __10__  total employees supervised

Management Scope

• Check appropriate decision-making authority below:
• Decisions with long-term impact
• With little-to-no supervisory review
• With supervisory review/approval required
• Decisions with short-term impact
• With little-to-no supervisory review
• With supervisory review/approval required