Senior Engineer (Downstream Process Development and Manufacturing)

Job Description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Job Overview

Snapdragon Chemistry, a Cambrex Company, is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where organic chemistry underpins product development.

We rely on our most valuable resource – our people – to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in flow chemistry and product development while also cultivating and furthering your career. At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture.

We are currently seeking exceptional candidates for Senior Engineer, downstream process development and manufacturing position at its Waltham, MA site. A successful candidate will be joining a group of innovative and entrepreneurial scientists, with broad deliverables including the development of reactor systems and purifications for batch and continuous flow processes, delivery of high quality, complex chemical matters to our clients, and transferring process technology to clients at their facility.

We are looking for candidates who have a passion for working in a fast-paced, dynamic environment. The ideal candidate will have a degree in chemical engineering with experience and a passion for developing new process technology. The candidate should enjoy building equipment and carrying out experiments in a laboratory environment and scaling them up for engineering batch and cGMP manufacturing. The candidate should be well versed in separation and purification techniques, such as chromatography, filtration, TFF and lyophilization or freezer drying. Experience with continuous chromatography is preferred but not required. Candidates must possess strong written and oral communication skills.

Responsibilities

Duties and Responsibilities

• Develop and optimize multi-dimensional purification strategies (RP-HPLC, IEX, TFF) using mechanistic modeling and first-principles knowledge
• Lead the development and optimize freeze-drying cycles by determining critical process parameters (CPPs) to achieve target residual moisture.
• Act as the Subject Matter Expert (SME) in purification, lyophilization process development, characterization, and troubleshooting.
• Perform studies to scale-up from analytical scale purification to multi-kilogram production scale purification.
• Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stakeholders.
• Work with our team and with external vendor partners design and construct complex reactor platforms and components.
• Support system qualification, process validation, and ongoing system upgrades at external manufacturing sites.
• Support clinical-stage API manufacturing at our facility and process transfer to external sites.
• Maintain up-to-­date knowledge of continuous flow technology, process development principles, and best practices for regulated pharmaceutical manufacturing.
• Ability to independently design and resolve complex process development problems with little to no oversight.
• Ability to lead teams and mentor junior engineers.
• Serve as a general chemical engineering resource to the organization.

Qualifications/Skills

Required Experience and Skills:

• Demonstrated ability to take initiative, be creative and innovative, and work productively and efficiently.
• Ability to solve complex chemical engineering problems.
• Strong written and oral communication skills.
• Excellent collaboration skills, team-oriented and invested in the success of others.
• Ability and demonstrated willingness to comply with, and encourage amongst others, the ethical and cultural standards of Snapdragon Chemistry.

Preferred Experience and Skills:

• Demonstrated to work in a kilo lab environment using glass reactor equipment
• Demonstrated ability to put together and/or follow batch records in a GMP environment
• Working understanding of ICH and FDA guidelines for GMP manufacture

Education, Experience & Licensing Requirements

Education, Experience, and Other Qualifications

Bachelor’s or master’s degree in chemical engineering with 5-10 years of experience OR PhD in Chemical Engineering with 0-2 years of experience

Physical Demands, Work Environment, and Travel

Travel: Not Applicable

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee must regularly stand and bend, and climb; and is frequently required to sit and walk, crawl, stoop. Employee must frequently use hands to finger, handle or feel objects, tools or controls. Must be able to talk and hear. Employee must frequently lift and/or move up to 75 pounds and able to move drums or pallets of up to 2,400 pounds with use of drum truck, pallet jack, or fork lift. Specific vision ability required by this job includes close vision, distance vision, depth perception, and the ability to adjust focus, and observe color changes.

Environment and Protective Equipment:

The work environment characteristics described here are representative of those an employee

encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Incumbent will have duties in the control room as well as in the outside production unit. The outside production unit consists of multi-level areas accessible by stairs and ladders. There are also isolated, environmentally controlled rooms used for raw material charging and final product drumming. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The noise level is moderate to loud. Frequently, employee is exposed to airborne particles and fumes. Employee is exposed to various chemicals.

The estimated salary range of $102,184 - $110,359 reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, and certifications or other professional licenses held. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.