MSAT Principal Analytical Chemist

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

Performs and leads troubleshooting, process & compliance improvements, and potential introduction of new analytical technology. Accountable for continuous improvements which include, but are not limited to, cleaning development, waste stream analysis, in process and release testing, and raw material specification/testing for commercial products.

A key function of this role is to help reduce operating costs and defects while maintaining high throughput and overall compliance. This role will also directly support investigations into processes in commercial manufacturing and work on continuous improvements for the Production Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Ensure cGMP compliance, compliance to internal procedures, accuracy, and scientific soundness in support of commercial production
• Provides written analytical procedures and reports supporting commercial manufacturing, as well as incoming commercial products (Phase III or undergoing validation). Facilitates and supports analytical technology transfers
• Trains peers in new methods or improvements to current methods and establishes work standards for the group
• Supports commercial production to help drive higher throughput, lower costs, and improved robustness through continuous improvement of analytical methods and material specifications
• Develops, authors, or reviews robust analytical methods and specifications for commercial products (raw materials, intermediates, drug substances), including change controls
• Aids in support of vendor changes to raw materials, or specifications, or improvements to these areas both for legacy processes as well as new incoming processes
• Implements technology transfers for new analytical technology or techniques that are required for commercial processing or will help drive improvements for the site and ensure robustness
• Evaluates emerging technology for potential implementation as needed to improve profitability, robustness, and compliance
• Leads the establishment, implementation, and maintenance of a system of work standards within the framework of site procedures and regulatory guidance for MSAT activities
• Collaborates with Quality Control and Development to help tech transfer methods and ensure knowledge sharing across groups to drive standard work across departments in regard to analytical methods
• Works with Operations Department, Deviation Team, Training Group, and Analytical Development to identify larger trends with analytical methods or analytical failures; and ensure appropriate CAPAs; and follow on projects or update to current standards
• Ability to conduct root cause analysis for analytical related failures and identify correct preventative and corrective actions from their own investigation

LEADERSHIP & BUDGET RESPONSIBILITIES

Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. Expected to work interactively and collaboratively across departments as well as leading conversations with external clients.

May mentor and indirectly lead 1 - 5 employees but has no direct reports. Carries out leadership responsibilities in accordance with Corden policies and applicable laws. Responsibilities include training employees, helping with work level loading, and mentoring colleagues in the group and within the development department.

Supervisory responsibilities include daily leadership of team; training and development: interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

A PhD in Chemistry/Analytical Chemistry or equivalent combination education and work experience. Three years of practical work experience in API pharmaceutical processing, including all aspects of analytical chemistry support from scale-up and API Regulatory approval processes. Advanced communication skills necessary to interrelate with external customers and other departments within the company structure.

LANGUAGE SKILLS

Ability to write reports, proposals, contracts, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to convert units of measurement.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

Green Belt or Black Belt certification is a plus.

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 job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.

WORK ENVIRONMENT

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.

While performing the duties of this job, the employee frequently uses toxic and/or caustic chemicals as well as high potent compounds, and there is a risk of exposure. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity. The candidate must be able to put into use the following core competencies:

• Scientific leadership in analytical chemistry for API synthesis
• Communication – excellent oral and written communication
• Analytical Methodologies – HPLC/UPLC, Mass spec, GC, HS-GC, IR, UV, IC, ICP-MS, NMR, and other common techniques supporting commercial production, IPC testing, and drug substance testing (and associated instruments)
• Regulatory Compliance – Excellent working knowledge of ICH Guidelines, compendia (USP/EP/JP), and FDA Regulatory guidance documents. May support audits/inspections as a subject matter expert
• Advanced troubleshooting for analytical methods
• Quality Compliance – Performing and supporting investigations, determination of root cause, and preventative measures

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance