Laboratory Trainer

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

Responsible for the Laboratory Training Program for the Analytical Development, Process Chemistry, Quality Control, and Standards and Stability Groups. Primary focus is to assess training needs in these areas and work with SMEs to develop and deliver training to meet those needs. This includes onboarding training and training progression tracking of new hire chemists, as well as skill enhancing training of existing staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned

• Ensures efficient, effective, and rapid introduction of new employee resources into these departments. Acts as the primary resource to introduce value, cultural, and behavioral expectations to new Chemists
• Delivers in person training to staff as appropriate. Leads the development and improvement of training documents for analytical instrumentation, methods, and method development with input from SMEs and management
• Coordinates hands on training with SMEs or contractors for analytical instrumentation, methods, troubleshooting, and improvement, as needed, to close any knowledge gaps or help with department skill development.
• Identify and implement improved training methods to increase employee effectiveness. This includes developing or enhancing in-house programs and practices to identify developmental needs, including personnel growth, and increasing effectiveness in present assignments
• Perform training needs assessments to ensure training is being implemented where necessary. Follow up with employees and Group Leaders to ensure adequate time is given to complete training in a reasonable timeframe
• Work with the HR Training Department to continue to improve the training system and how training is initiated, executed, and tracked.
• Collaborate with EHS Group to ensure that safe lab practices are being used and incorporate all relevant safety information. Review incident reports related to lab practices and work with EHS to identify any potential gaps or contributing factors.
• Work with departments teams and operational excellence to help train people on the use of 5S and other best established work practices.
• Assist with efforts to improve and streamline method development, method transfer, method validation, and analytical instrument operation across the site. Work with other sites in the Corden Pharma network as needed to drive continuous improvement.
• Collaborate with Quality Assurance and Quality Control Teams to ensure that training and current best practices support effective method transfer. Gather feedback and implement updated training/coaching to ensure that all GMP documents and reports meet current industry standards and are in compliance.
• Help identify and train SMEs to ensure all technologies have a local expert that can assist with issues for specific technologies. Work with those SMEs to continuously improve the best practices and ensure that Organizational Change Management (OCM) is used when rolling out new workflows or procedures
• Participates in related site activities, such as troubleshooting and analytical problem resolving, and incorporating any learnings or changes to the training program, including CAPAs for any department related deviations or incidents.
• Work with Group Leaders and Department managers to develop any performance enhancement or performance improvement plans as it relates to training
• Practices good communication skills, both written and verbal, as well as great presentation skills
• Develops an understanding of QEH&S principles and regulatory affairs to aid with development of analytical training

LEADERSHIP & BUDGET RESPONSIBILITIES

Expected to work interactively and collaboratively in a project team environment. Demonstrates positive attitude. Supports a positive, healthy and flexible work environment that encourages employees and coworkers to develop their full potential.

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.

As a training position, the expectation is also that this role will help to coach and reinforce safe work practices within the group.

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

Bachelors degree with 5 years of experience in analytical chemistry.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents. Ability to translate technical documents and information into clear, concise training information. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply statistical concepts such as significant figures, frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

Domestic and international travel may be required.

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 work with hands; and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

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 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.

• Presentation and persuasion skills
• Training and facilitation skills
• Developed written and verbal communication skills
• Technical writing and interactive training development skills
• Complete understanding of cGMP and GLP

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

Job expires on 6/8/2024