Summary of Role
The Senior/Principal Process Development Scientist - HPAPIs is accountable for driving the development and optimization of robust, scalable synthetic processes for small molecule APIs - with a focus on highly potent active pharmaceutical ingredients (HPAPIs), payloads, linkers, payload-linker intermediates - from early development to technology transfer into manufacturing, in a fast paced CDMO environment. The incumbent will write and review technical documents including SOPs, training modules, technical transfer documents, specifications, and development reports to be sent to clients or used in regulatory filings and is responsible for ensuring complex technical information is well understood by team associates, management and clients. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
The role requires expertise in the development of synthetic routes and scalable manufacturing processes for highly potent compounds, including antibody-drug conjugate (ADC) payloads, linker technologies, payload-linker intermediates, and related HPAPI molecules, with a strong focus on safety, containment, and successful transfer into cGMP manufacturing environments.
Essential Functions
As a part of a cross-functional development team, designs, plans, and executes process development and optimization for HPAPIs, payloads, linkers, payload-linker intermediates, and small molecule APIs, with ownership of synthetic strategy through to robust, scalable processes with minimal supervision.
Performs process characterization through techniques such as Design of Experiments (DOE), and impurity fate/purge studies to understand and control critical process parameters, including those relevant to highly potent compounds and payload-linker syntheses.
Oversees and supports lab to plant scale-up activities providing on site support as needed for critical operations and troubleshooting, including collaboration with analytical, quality, EHS, and manufacturing colleagues to ensure programs are delivered right first time while meeting containment and safe handling requirements for highly potent compounds.
Executes synthesis activities from gram to multi-kilogram scale at up to 20 L scale, including routine maintenance and troubleshooting of laboratory equipment, containment systems, and engineering controls utilized for handling HPAPIs and payload-linker intermediates.
Isolates and purifies products and intermediates by using standard laboratory techniques, including automated preparative chromatography systems.
Designs multi-step synthetic processes from commercially available starting materials to target compounds, including ADC payloads, linker molecules, payload-linker intermediates, highly potent cytotoxic agents, and related pharmaceutical compounds.
Performs routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, LC-MS, KF), and interprets and communicates data effectively, including assessment of impurity profiles and product quality attributes.
Prepares project documentation such as development reports, material specifications, containment assessments, and technology transfers of high technical complexity with minimal supervision.
Serves as a chemistry technical lead and point of contact for client technical representatives during project meetings, technical reviews and site visits.
Establishes and coordinates activities at contract chemical and analytical laboratories, as required.
Ensures timely completion and compliance with cGMP, Safety, and all other relevant company training requirements.
Provides technical leadership in the safe handling, process development, scale-up, and manufacture of HPAPIs, payloads, and linker technologies, while mentoring, training, and coaching junior scientists.
Contributes to the evaluation, implementation, and continuous improvement of containment strategies, risk assessments, and operational practices associated with highly potent compounds.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Key Competencies
Understands reaction mechanisms and can apply them to practical execution of given synthesis.
Knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals, HPAPIs, ADC payloads, linker molecules, payload-linker intermediates, and related organic molecules.
Proficiency in hands-on execution of analytical techniques such as HPLC, GC, NMR etc.
Demonstrates technical ability to independently design and execute non-routine experiments.
Demonstrates ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up with minimal supervision.
Demonstrated understanding of containment practices, occupational exposure controls, risk assessments, and safe handling procedures associated with highly potent compounds.
Knowledge of synthetic route design, process optimization, impurity control strategies, and scale-up considerations for HPAPIs.
Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations and write reports, business correspondence and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Ability to perform complex math functions, compute ratios, rates and percentages while drawing and interpreting graphs and charts.
Demonstrates a strong working knowledge of GMP principles and expectations for HPAPI and API development, as well as relevant regulatory requirements.
Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
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.
Education and Experience
Required:
Demonstrated experience in synthetic route development, reaction optimization, and scale-up for HPAPIs and Payload Linkers.
Demonstrated experience working with highly potent compounds, including knowledge of containment strategies, occupational exposure controls, and safe laboratory practices.
Bachelor's degree in Chemistry or related field required with minimum of 15+ years' experience OR Master's degree in Chemistry or related field with minimum of 9+ years' experience, OR PhD in Organic Chemistry or related field with a 5+ years of previous experience.
The level of this position – Senior or Principal Scientist - will be determined based on the experience of the candidate.
Preferred:
Experience working within a CDMO or other fast paced development environment.
Experience supporting development and scale-up of ADC payloads, linker technologies, payload-linker intermediates, or other highly potent pharmaceutical compounds.
Track record of mentoring or managing junior scientists in a laboratory environment.
Travel Requirement
Up to 5%
What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.
Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent . Be willing. Be reliable.
