Formulation technician; Expert in pharmacokinetics and metabolism; Pharmaceutical development technician.

The development of a new drug involves a process that includes studying its reaction to different pathologies and evaluating its side effects. A drug's capabilities and effectiveness largely depend on its final presentation, how it is taken and the components accompanying the active ingredient. Drug development technicians are in charge of optimising the various stages leading to the final prodcut, including formulation and stability, studying its pharmacological activity and pharmacokinetics (absorption, distribution, metabolism and excretion) and obtaining the final dosage form or pharmaceutical development (tablets, injectables, creams, etc.). Their role is a bridge between different departments involved in pharmaceutical development, as they work closely with research staff, analytical development technicians, clinical trial monitors, production heads and experts in registrations. All studies should be conducted according to current quality standards described in the company's Quality Control Systems Handbook, to standard operating procedures and to detailed instructions in external reference documents (good laboratory, manufacturing and clinical practices, ICH, Phamacopoeia and other specific guides and standards).

• Supervise the design and implementation of formulation studies and pharmaceutical development.
  Coordinate the design of formulations and the perfection and validation of the scaling processes and manufacturing of formulations.
  Perform activities and experiments supporting development of the formulation and dosage form, including determinations of solubility, compatibility studies, biodegradation, formulation sampling, temperature cycles and physical evaluation of the products.
  Establish the physico-chemical and pharmacotechnical specifications of new developments.
  Coordinate stability studies of new drugs.
  Supervise the work of analysts and operators assigned to development.
• Conduct pharmacological and pharmacokinetic studies under rules of good laboratory practices, and directly supervise the person in charge of the study.
  Approve study protocol, write related Standard Operating Procedures (SOPs) and record original data generated.
  Conduct pharmacological, toxicological and metabolic studies in cell cultures and animal models for the different diseases.
  Coordinate necessary tasks and timing until obtaining final reports.
  Interact and communicate with workers in the same and other related departments to ensure timing will be met.
  Evaluate results from pharmacokinetic, toxiconetic and metabolic studies using mathematical analysis models of linear and non-linear regression, including estimation of pharmacokinetic parameters, conducting of simulations and determination of enzyme kinetic parameters.
• Help draft and review protocols for clinical studies phase I, II and III.
  Prepare samples for clinical testing.
  Stay in contact and collaborate with the clinical trial monitor, the head of medical affairs, the biostatistician and the metabolism specialist to design different protocols.
  Interpret pre-clinical and patient data in phase I to optimise dose, kinetic studies and presentations of the drug in the next stages and compile data and analysis methods used.
  Create kinetic models to simulate and predict drug concentration, activity and effects.
  Collect data and analyse the pharmacokinetic parameters of the different phases.
  Solve technical problems using statistical methods to evaluate and validate models.
  Be aware of the responsibilities of each department in data collection and analysis and data validation techniques.
• Prepare reports on clinical studies, technical presentations and biopharmaceutical sections of drug registration documents.
  Bring together all information in a clear and concise manner.
  Interpret study results and draw conclusions based on objectives posed.
  Provide regular reports based on the key results of the project.
  Be aware of regulatory requirements and regulations for drug registration.
• Provide technical support in the manufacturing process (scaling, pilot batch production and manufacture of the first regular production batches) and in the commercial launch of the new drug, once it has been registered and the feasibility of its production has been assured.
• Publish work depending on regulations and the degree of confidentiality necessary.
  Assess technical literature in the field.
  Integrate all analyses and interpretations in final reports.
  Collaborate in obtaining patents.
  

Regulated training and graduates

• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Pharmaceutical, biotechnological and Related Product Production
• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Laboratory for analysis and quality control
• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Chemical industry
• Grau: Bioquímica
• Grau: Bioquímica i biologia molecular
• Grau: Biotecnologia
• Grau: Química
• Grau: Enginyeria química
• Grau: Farmàcia
• Grau: Medicina
• Grau: Veterinària

Complementary training

Good knowledge of standards of good manufacturing practice (GMP) and good laboratory practice (GLP).
Knowledge of statistics and mathematical analysis methods.
Knowledge of biochemical and analytical techniques.
Specialisation in pharmacokinetics or formulation after completion of specialisation courses.
Employers look for complementary training in pharmaceutical development, primarily in designing solid, semi-solid and liquid forms, in delayed formulations and in selective delivery systems.
Knowledge of the pre-clinical development process and notions of clinical trial monitoring and process industrialisation.
Continued company financed training either in outside training centers or in the company with experienced technicians.

Other specific skills

Knowledge of office automation and Internet at a user level.
Experience in literature searches and databases.
Good level of spoken and written English for international scientific and technical contacts (advanced level).
Accustomed to working in multidisciplinary teams.
Ability to write technical documents in English.
Experience in drafting SOPs and other documentation on rules and regulations for good practices.
Knowledge of software packages for kinetic analysis (WINNONLIN, NONMEN, SPLUS...).
Knowledge of management and organizational skills.

Analytical thought: Level 3

Concern for order and quality: Level 3

Leadership: Level 2

Conceptual thought: Level 3

Strategic orientation: Level 2

Learning and use of knowledge: Level 3

Management

The organisation, administration and control of a company or entity are the main interests of people related to the management field. Activities included in this field of interest vary from effective resource management, feasibility analyses and solving business problems to the development of skills and fostering of motivation in relation to human resources. Knowledge regarding specific techniques of strategic administration and business management are required to carry out these activities.

Scientific research

Individuals who have an affinity for the field of scientific research focus their interest on activities that study different types of organisms and substances in order to obtain valuable products for human beings. A key part of performing this task is the planning and verification of scientific hypotheses through the use of different research designs and techniques. The objective of these searches is the development of new medicines and medical techniques, technological innovation based on the manipulation of cells, molecules and biological agents, as well as the study of cultures in order to improve the characteristics and properties of plants and food.

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Computational chemistry technician

• Work hours

  Working days are usually full-time and can be continuous or split, depending on company needs and policy. Schedules are usually flexible, depending on the phase of development of the drugs under study. Working days may be part-time for external collaborators who perform tasks for a company related to a project or specific function.

• Salary

  Salary for this occupation depends on experience, relevant skills and degree of responsibility acquired after joining the company. Gross salary is between 23.421 and 34.509euros a year initially and may be higher depending on the kind of products obtained by the company. Median: 28.428 euros annum gross. In some multinational companies, there may be incentives based on success in the development of a specific drug or on the attainment of new applications or dosage forms that reach the market.
  
  Source: Report "Observatory of Jobs and Salaries of the Labour Market. Barcelona Activa", elaborated by ICSA Grupo. April 2015.
  
  

• Professional category

  Technician