Analytical Development Scientist
This Performance Model outlines the competencies for the Analytical Development Scientist for Tedor Pharmaceutical Inc.
Tedor is a privately held pharmaceutical company that develops and/or commercially manufactures generic drug products via the ANDA process as a CDMO model. Tedor also offers IND applications requiring drug product development and cGMP manufacturing through either a 505b2 route or the NDA process.
The role of the Analytical Development Scientist includes performing tasks such as:
- To acquire knowledge by performing extensive literature search from various available resources.
- To review RFP and provide inputs as required
- Involved in planning research activities and experiments that support the development of methods for analysis of new products or modification of existing products to meet customer specifications and regulatory requirements
- Provide research based, strategic solution to develop and validate analytical methods which will optimize project performance and comply to USFDA and other regulatory requirements.
- Involved in critical thinking & testing to determine the appropriate solutions for the challenges in a project. interpret and analyze experimental data to identify the next steps to be taken
- Involved in evaluating, developing, routine testing and validating the methods for immediate release or extended release formulations (tablets, capsules, pellets etc.)
- Involved in handling of controlled substances Schedule I (R & D) to Schedule V
- Involved in abuse deterrent testing as required.
- Assists in evaluation and testing of raw materials, in-process and finished dosage forms
- Communicate internally and externally with project clients/stakeholders, suppliers and internal staff to support project advancement and improving transparency & distributing timely information about the project.
- Managing multiple projects simultaneously.
- Provide updates as required to production, QA, RA and QC departments and to clients,
- Assist Manager in providing strategic inputs for the project advancement.
- Review technical documents in collaboration with other scientists and formulation development for laboratory notebooks, batch records, project summaries, development reports, sampling and testing protocols, planned deviation reports, incident reports, and change control forms.
- Support and coordinate the recruitment process of new hires and the development of team.
- Supervise/train junior analytical chemists or scientists, technicians and ensure their activities comply with organizational goals and departmental cGMP/ cGLP regulations.
- Assists in FDA filings.
The AD Scientist Performance Model
To be successful in the AD Scientist role an individual must possess the competencies listed below and be able to produce the necessary performance outcomes.
The competencies for the AD Scientist role are divided into two pillars – Job Specific and Organizational competencies. The job specific competencies identify the technical skills one must possess in the AD Scientist role to be successful. The organizational competencies identify the broad skills and behaviors everyone at Tedor must possess and apply to drive organizational results.
|Job Specific Competencies||Organizational Competencies|
|Analytical Thinking||Achievement Orientation|
|Attention to Detail||Adaptability|
|Communication – Oral & Written||Initiative*|
|Teamwork and Cooperation*|
|Hands on approach|
*Note: Two of the organizational competencies – Initiative and Teamwork and Cooperation – were observed to also be important job specific competencies for the AD Scientist role. The definitions of these two competencies remain the same and critical outcomes from the organizational model are included along within the outcomes list for each of these two competencies.
Every job can be measured in terms of performance outcomes. Outcomes serve as a way to evaluate performance, identify development opportunities, as well as provide individuals within a given role – clarity on what their actions must produce. For the purposes of this performance model an outcome is defined as:
The output or end result of a set of actions by a performer that is directly linked to producing a desired business result
|AD Scientist Core Performance Outcomes|
Level 1: office Environment and Production Environment
This job operates in a professional office environment as well as in the Production and Warehouse environment. This role routinely uses standard office equipment such as computers, phone photocopiers, filing cabinets and fax machines, at times the analytical scientist may be required to work in the production environment.
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. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; use hands, handles, and should be able to perform the physical demands of the job. Must be able to lift 10 pounds.
Position Type and Expected Hours of Work
This is a full-time position requiring a minimum of 40 hours of work per week Monday through Friday. Some responsibilities may require work outside of normal office hours.
Minimal travel is expected for this position.
Required Education and Experience
Bachelor’s Degree in Chemistry required.
Proficiency in computer usage and Microsoft office required.
- 6 – 10 years chemistry related experience
- Experience in solid oral dose testing and method development/validation.
- Proficiency in using computer, Microsoft Office Suite of products, ERP systems, etc.
Preferred Education and Experience
- Master’s Degree or Ph.D. in Chemistry, Pharmaceutical Sciences or any relevant degree.
- 7 – 10 years of directly related experience in solid oral dose solid oral dose testing and method development/validation .
- Five years experience in a CMO or service-based organization.
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. Duties, responsibilities and activities may change at any time with or without notice.
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