Senior/Staff Process Scientist

Siegfried Wilmington is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement of opioid and non-opioid products in a range of therapeutic applications.

Specialists in controlled substance development and manufacturing -

– Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
– High-purity controlled substances from narcotic raw materials
– Formulation-friendly particle size grades and extended technical packages
– Supporting world-class supply security of controlled substances, from schedule I to schedule III

GENERAL PURPOSE OF JOB

This position’s key function is to provide real time process chemistry support as part of the Scientific Affairs Organization by conducting research in assigned areas using established methodology or by developing new methodologies where required. Specific responsibilities include: Performing scientific experiments according to existing, approved methods, troubleshooting plant processes to resolve problems, utilize complex analytical techniques to guide research, serve as a technical resource. Incumbents will partner with Analytical Scientists, New Product Development and Technical Transfer team, Quality Control, Process Engineering and Operations groups.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Performs synthetic and process chemistry in support of core department efforts (such as process development, production support, impurity synthesis) by following established processes and procedures, as well as recommending and utilizing published organic methodologies where required. Have full working knowledge of chemical processes, development, scale-up and manufacturing as they pertain to Noramco products and capabilities.
• Effectively and accurately operates standard laboratory equipment required to conduct synthetic experiments (such as temperature control units, vacuum pump, drying oven, rotovap, etc). Advanced knowledge of synthetic/organic techniques (such as reflux, distillations, crystallizations, purifications, synthetic methodologies). Familiar with pilot/production chemical processing and equipment. Can train others on basic synthetic/organic techniques and support equipment.
• Understand theory and application of complex analytical techniques (such as HPLC, GC, IR, NMR). Ability to perform routine tests following established procedures and interpret output data.
• Assists in the evaluation and implementation of new technologies and instrumentation.
• Manages process elements of projects such as new product development and introductions, as well as technical transfer to pilot/production scale.
• Conducts troubleshooting of plant processes to resolve production or quality problems. Conducts experiments and applies trouble shooting techniques to ensure adequate resolution and recommend path forward. Evaluates new raw material sources to ensure adequate performance in production, and makes appropriate recommendation. Serves as consultant/technical resource to production/engineering/quality control in areas of expertise.
• Develops new and maintains existing laboratory procedures, technical report and standard
• operating procedures. Technical reports must include recommendations that are data based and technically-sound, requiring minimal corrections. Lead criticality assessment and write regulatory documentation with general understanding of impacts to the company. Working knowledge of Noramco documentation and associated systems (such as D2LS, Trackwise, eLIMS, SAP).
• Maintains and provides notebooks, records, reports, action/check lists and documentation which are current, legible, readily understood, complete and accurate to insure compliance with established procedures and specifications, and are verifiable as required or requested. Reviews fellow scientist's work, including complex records of experimentation, to ensure completeness and accuracy.
• Provides advice and consultation on routine and non-routine process and organic chemistry technical issues in areas of expertise. Consults with more senior scientists and management where appropriate.
• Coordinates and collaborates with internal business partners to execute technical transfers and implement new processes within area of expertise.
• Plans, designs, and conducts research within area of expertise. Analyzes and interprets the results, and summarizes findings for presentation. Collaborates and consults with more senior scientists and managements as needed.
• Provides solutions to problems of limited to moderate scope and complexity. Exercises judgment within generally defined policies and procedures to determine appropriate action. Consults other scientists and management as appropriate.
• Routinely interacts with internal laboratory personnel and vendors. May interact with external customer or business partners and contract labs as necessary.
• On a project basis may assist with the procurement, installation and calibration of laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate data. May assist with the setup, IQ, OQ and PQ of new equipment.
• Trains new laboratory personnel in Noramco procedures/processes and equipment. May train others in new processes/technology or equipment depending on area of expertise in accordance to internal procedures and guidelines.
• Practices continuous improvement in the development of new or refined materials, processes, products and/or scientific/business procedures and processes.
• Makes decisions regarding analyzing and interpreting data, drawing conclusions, and arriving at timely technical decisions.
• Performs other appropriate duties as assigned by the Technical Support Manager.

ADDITIONAL POSITION REQUIREMENTS

• Interfaces with multiple departments on a routine basis.
• Requires thorough understanding and advanced knowledge of all test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances associated with NORAMCO, Inc.
• Understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, precise and accurate data generation using established methods and procedures.
• Maintains an adequately supplied, properly cleaned and safe laboratory to minimize delays, errors and mishaps by using good laboratory and housekeeping practices.
• Ability to make independent decisions within general guidelines and to work under minimum supervision.
• Maintain and comply with all regulatory programs and guidelines to ensure that all current
• Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) requirements are met.
• Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
• Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties. Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
• Complies with all regulatory and job training requirements to perform duties of the job.
• Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), plus all other relevant job requirements.
• Must be available for overtime work on a scheduled or emergency basis.
• Remains current in skills and industry trends.

SUPERVISORY RESPONSIBILITIES

None. May provide work or task direction to new employees, temporary assignees or co-op students.

EDUCATION and/or EXPERIENCE

• B.S. in Chemistry or related science; Masters or Ph.D in Synthetic Organic Chemistry is highly preferred.
• 4-6 years experience in synthetic/organic chemistry required. Direct experience in process development and/or scale up preferred.
• Advanced knowledge of cGMP/cGLP regulations is required. Basic knowledge of pharmaceutical manufacturing and chemical practices/processes is required.

LANGUAGE SKILLS

• Read, analyze, and interpret the moderately complex technical and regulatory documents.
• Regularly responds effectively to inquiries or complaints from client groups, customers and regulatory agencies.
• Ability to write moderately complex technical reports, business correspondence and technical procedural instructions/manuals.
• Creates presentations using original or innovative techniques, as well as established template formatting.
• Ability to effectively present information and respond to questions from groups of managers, employees, top management, public groups, and/or boards of directors. Makes effective and persuasive presentations on moderately controversial or complex topics.

MATHEMATICAL SKILLS

• Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in highly complex phases.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• Advanced knowledge of laboratory instrumentation use and routine preventative maintenance.
• Use computer software and customized programs to meet business needs, including word processing and mathematical applications.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Must be able to work with people, influencing their output and work behavior.
• Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.
• Ability to perform under stress in cases of emergency, critical or hazardous situations.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is frequently required to stand; walk; sit; reach with hands and arms, use hands to finger, handle, or feel.
• Must have fine motor skills to perform precise laboratory manipulations.
• The employee is occasionally required to: climb or balance; stoop, kneel, crouch, or crawl.
• The employee must regularly lift and/or move up to 10 pounds; occasionally lift and/or move up 40 pounds.
• Specific vision abilities required by this job include close vision, peripheral vision, depth perception, color vision, and ability to adjust focus.
• Must be able to qualify for respiratory protective equipment use, and must be able to smell surrounding environments.

We strive to treat candidates as well as employees without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.

Job Type: Full-time

Pay: $110,000.00 - $150,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: In person

Salary : $110,000 - $150,000